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What changed in TransMedics Group, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of TransMedics Group, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+434 added−390 removedSource: 10-K (2026-02-24) vs 10-K (2025-02-27)

Top changes in TransMedics Group, Inc.'s 2025 10-K

434 paragraphs added · 390 removed · 332 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

93 edited+25 added−12 removed196 unchanged
Biggest changeWe believe the results of our clinical trials across lung, heart and liver transplantation may support the potential of the OCS in improving clinical outcomes and increasing utilization of available donor organs.
Biggest changeWe believe the results of our clinical trials across lung, heart and liver transplantation may support the potential of the OCS in improving clinical outcomes and increasing utilization of available donor organs. 9 The results of our clinical trials are summarized in the images below. . 10 OCS Clinical Trial Overview Table Next-Generation OCS Trials In August 2025 and January 2026, we received FDA approval under Investigational Device Exemptions, or IDEs, to initiate multi-part, prospective clinical trials for next-generation versions of our OCS Heart and OCS Lung systems, respectively.
We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. Our logistics services include aviation transportation, ground transportation, and other coordination activity.
We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. Our transplant logistics services include aviation transportation, ground transportation, and other coordination activity.
Our NOP provides transplant centers with the 3 ability to utilize the OCS to procure and transplant more organs for their patients than they would otherwise be able to do without increasing their own staff. In August 2023, we acquired Summit Aviation, Inc. and Northside Property Group, LLC, or together Summit.
Our NOP provides transplant centers with the ability to utilize the OCS to procure and transplant more organs for their patients than they would otherwise be able to do without increasing their own staff. 3 In August 2023, we acquired Summit Aviation, Inc. and Northside Property Group, LLC, or together Summit.
The OCS is a portable organ perfusion, optimization and monitoring system that utilizes our proprietary and customized technology to replicate near-physiologic conditions for donor organs outside of the human body.
The OCS is a portable organ perfusion, optimization and monitoring system that utilizes our proprietary and customized technology to replicate near-physiologic conditions for donor organs outside of the human body.
We believe that our principal competitive factors include: • strong clinical evidence from large trials demonstrating safety, effectiveness and clinical benefits; • superior technology; • our NOP, including clinical service and logistics services; • regulatory approvals for broad clinical indications of use; • ease of integration into current organ procurement workflow, including system portability across all modes of transportation; • platform capabilities designed to support multiple organ transplant programs; • brand recognition among leading transplant programs worldwide; • established clinical relationships and a core of committed clinical users; • commercial reimbursement; and • sophisticated clinical training and support program to users worldwide.
We believe that our principal competitive factors include: • strong clinical evidence from large trials demonstrating safety, effectiveness and clinical benefits; • superior technology; • our NOP, including clinical service and transplant logistics services; • regulatory approvals for broad clinical indications of use; • ease of integration into current organ procurement workflow, including system portability across all modes of transportation; • platform capabilities designed to support multiple organ transplant programs; • brand recognition among leading transplant programs worldwide; • established clinical relationships and a core of committed clinical users; • commercial reimbursement; and • sophisticated clinical training and support program to users worldwide.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: • warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; • recalls, withdrawals, or administrative detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying requests for approvals of PMAs of new products or modified products; • withdrawing a PMA approval that has already been granted; • refusal to grant export permits or certificates for our products; or 16 • criminal prosecution.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: • warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; • recalls, withdrawals, or administrative detention or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying requests for approvals of PMAs of new products or modified products; • withdrawing a PMA approval that has already been granted; • refusal to grant export permits or certificates for our products; or • criminal prosecution.
The expansion of our NOP to provide our own transportation logistics services, including 100% owned and operated private aircraft dedicated to organ procurement, further improves the efficiency of utilizing the NOP as a complete solution for organ procurement. 4 • Significant body of strong clinical evidence In order to receive FDA approval for our PMA products, we have conducted clinical trials with large numbers of patient participants, with the results of these trials published in leading medical journals.
The expansion of our NOP to provide our own transportation logistics services, including 100% owned and operated private aircraft dedicated to organ procurement, further improves the efficiency of utilizing the NOP as a complete solution for organ procurement. • Significant body of strong clinical evidence In order to receive FDA approval for our PMA products, we have conducted clinical trials with large numbers of patient participants, with the results of these trials published in leading medical journals.
It is well demonstrated that donor organs benefit from some form of optimization to replenish depleted levels of substrates, hormones, and electrolytes that are significantly altered or used up during the donation process. 5 • No organ viability assessment capability During cold storage, the organs are not physiologically active, nor functioning; thus, there are no means for evaluating the suitability of these organs for transplantation.
It is well demonstrated that donor organs benefit from some form of optimization to replenish depleted levels of substrates, hormones, and electrolytes that are significantly altered or used up during the donation process. • No organ viability assessment capability During cold storage, the organs are not physiologically active, nor functioning; thus, there are no means for evaluating the suitability of these organs for transplantation.
This further limits utilization of available organs as donor populations worldwide are growing older and have concomitant risk factors that benefit from sophisticated diagnostic evaluation capabilities to predict whether the donor organ is suitable and safe to transplant. Our Technology and Solution We developed the OCS to comprehensively address the major limitations of cold storage.
This further limits utilization of available organs as donor populations 5 worldwide are growing older and have concomitant risk factors that benefit from sophisticated diagnostic evaluation capabilities to predict whether the donor organ is suitable and safe to transplant. Our Technology and Solution We developed the OCS to comprehensively address the major limitations of cold storage.
These include: • establishment registration and device listing with the FDA; • QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; 15 • labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; • approval of a PMA supplement for certain modifications to PMA-approved devices that affect the safety or effectiveness of the device, or clearance of a new 510(k) premarket notification for modifications to 510(k) cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of the device; • medical device reporting regulations, which require that a manufacturer report to the FDA information that reasonably suggests a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; • complying with the federal law and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database; • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death; and • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
These include: • establishment registration and device listing with the FDA; • QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; • labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; • approval of a PMA supplement for certain modifications to PMA-approved devices that affect the safety or effectiveness of the device, or clearance of a new 510(k) premarket notification for modifications to 510(k) cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of the device; • medical device reporting regulations, which require that a manufacturer report to the FDA information that reasonably suggests a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur; • correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; • complying with the federal law and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database; • the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death; and 16 • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
Where personal data is being transferred outside the EEA (or the UK), it must be done in compliance with applicable data export requirements. Any failure by us or third parties to comply with applicable data laws, could lead to a security or privacy breach, regulatory enforcement, or regulatory, reputational or financial harm. 23 U.S.
Where personal data is being transferred outside the EEA (or the UK), it must be done in compliance with applicable data export requirements. Any failure by us or third parties to comply with applicable data laws, could lead to a security or privacy breach, regulatory enforcement, or regulatory, reputational or financial harm. U.S.
Examples of such laws include the Foreign Corrupt Practices Act, or the FCPA, the UK Bribery Act 2010 and the General Data Protection Regulation, or the GDPR. 21 The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state.
Examples of such laws include the Foreign Corrupt Practices Act, or the FCPA, the UK Bribery Act of 2010, or the Bribery Act, and the General Data Protection Regulation, or the GDPR. The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state.
We received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung. Adverse events and potential adverse events are monitored closely by regulatory authorities.
We received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung. 20 Adverse events and potential adverse events are monitored closely by regulatory authorities.
These laws include, without limitation, U.S. and foreign laws intended to prohibit or otherwise regulate activities that might result in fraud, abuse and bribery. 20 U.S. Laws U.S. federal healthcare fraud and abuse laws generally apply to our activities because our products are covered under federal healthcare programs such as Medicare and Medicaid.
These laws include, without limitation, U.S. and foreign laws intended to prohibit or otherwise regulate activities that might result in fraud, abuse and bribery. U.S. Laws U.S. federal healthcare fraud and abuse laws generally apply to our activities because our products are covered under federal healthcare programs such as Medicare and Medicaid.
Any failure to comply with laws and regulations relating to reimbursement and healthcare goods and services could adversely affect our reputation, business, financial condition and cash flows. International Laws Many foreign countries have similar laws relating to healthcare fraud and abuse. Foreign laws and regulations may vary greatly from country to country.
Any failure to comply with laws and regulations relating to reimbursement and healthcare goods and services could adversely affect our reputation, business, financial condition and cash flows. 21 International Laws Many foreign countries have similar laws relating to healthcare fraud and abuse. Foreign laws and regulations may vary greatly from country to country.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting a substantial equivalence determination that provides permission to commercially distribute the device.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) 14 of the FDCA requesting a substantial equivalence determination that provides permission to commercially distribute the device.
Our NOP enables transplant centers to outsource the organ procurement, OCS perfusion management and transplant logistics process to our trained organ procurement surgeons, clinical specialists and transplant and logistics coordinators using our OCS products. Our offering allows the transplant center to focus their internal resources on the transplant surgery and patient care.
Our NOP enables transplant centers to outsource the organ procurement, OCS perfusion management and transplant logistics process to our trained organ procurement surgeons, clinical specialists and transplant and logistics coordinators while using our OCS products. Our offering allows the transplant center to focus their internal resources on the transplant surgery and patient care.
We also continue to collect clinical data through post-market registries for all of our products and plan to continue to provide the scientific results of these registries to the clinical user community.
We also continue to collect clinical data 4 through post-market registries for all of our products and plan to continue to provide the scientific results of these registries to the clinical user community.
Summit was a charter flight operator based in Bozeman, Montana. The acquisition enabled us to add aircraft transportation services to our NOP and become a comprehensive national provider of donor organ procurement and delivery in the United States. We have also acquired 21 fixed-wing aircraft to transport donor organs as part of the services offered under our NOP.
Summit was a charter flight operator based in Bozeman, Montana. The acquisition enabled us to add aircraft transportation services to our NOP and become a comprehensive national provider of donor organ procurement and delivery in the United States. We have also acquired 22 fixed-wing aircraft to transport donor organs as part of the services offered under our NOP.
For more information, see “Item 1A. Risk Factors—Risks Related to Our Intellectual Property” in this Annual Report on Form 10-K. 11 Competition Competition in organ preservation for transplantation can be classified into two main segments: (1) cold storage and cold perfusion technologies and (2) warm perfusion technologies.
For more information, see “Item 1A. Risk Factors—Risks Related to Our Intellectual Property” in this Annual Report on Form 10-K. 12 Competition Competition in organ preservation for transplantation can be classified into two main segments: (1) cold storage and cold perfusion technologies and (2) warm perfusion technologies.
All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption, or IDE, regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of study review and approval, informed consent, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
All clinical investigations of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of study review and approval, informed consent, recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.
As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain compliance with the QSR or other applicable regulatory requirements could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.
As a manufacturer, our facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain compliance with the QMSR or other applicable regulatory requirements could result in the shutdown of, or restrictions on, our manufacturing operations and the recall or seizure of our products.
As of December 31, 2024, our patent portfolio relating to the OCS Liver or liver transplantation technology includes a family of issued and pending patent applications with claims that are generally directed to certain systems, including perfusion circuits for perfusing a liver ex vivo.
As of December 31, 2025, our patent portfolio relating to the OCS Liver or liver transplantation technology includes a family of issued and pending patent applications with claims that are generally directed to certain systems, including perfusion circuits for perfusing a liver ex vivo.
As of December 31, 2024, our patent portfolio relating to the OCS Heart or heart transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a heart ex vivo.
As of December 31, 2025, our patent portfolio relating to the OCS Heart or heart transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a heart ex vivo.
Our manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
Our manufacturing processes are required to comply with the applicable portions of the QMSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.
If granted, the pending U.S. and foreign patent applications in our portfolio are expected to expire between 2025 and 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. 10 As of December 31, 2024, our patent portfolio relating to the OCS Lung or lung transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a lung ex vivo using both perfusion and ventilation.
If granted, the pending U.S. and foreign patent applications in our portfolio are expected to expire between 2026 and 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. 11 As of December 31, 2025, our patent portfolio relating to the OCS Lung or lung transplantation technology includes families comprised of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a lung ex vivo using both perfusion and ventilation.
Utilizing our NOP saves the transplant center from investing in additional resources to support higher volumes and longer distance procurements. Since the launch of the NOP, our sales of the OCS have primarily been through the NOP.
Utilizing our NOP saves the transplant center from investing in additional resources to support higher volumes and longer distance procurements. Since the launch of the NOP in the U.S., our sales of the OCS have primarily been through the NOP.
Class I includes devices with the lowest risk to the patient and/or the user and are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events and device malfunctions, and truthful and non-misleading labeling, advertising, and promotional materials.
Class I includes devices with the lowest risk to the patient and/or the user and are those for which safety and effectiveness can be reasonably assured by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the Quality Management System Regulation, or QMSR (that recently replaced the Quality System Regulation (QSR), facility registration and product listing, reporting of adverse medical events and device malfunctions, and truthful and non-misleading labeling, advertising, and promotional materials.
All of our international customers and a small number of our U.S. customers purchase our OCS products through the direct acquisition model. Reimbursement Medicare’s reimbursement for organ transplant procedures is well-established and involves two payment mechanisms.
Through 2025, all of our international customers and a small number of our U.S. customers purchased our OCS products through the direct acquisition model. 8 Reimbursement Medicare’s reimbursement for organ transplant procedures is well-established and involves two payment mechanisms.
While we are not directly affected by this regulation and guideline, our UK customers are, and our products may either help or impede their compliance with this regulation. 19 Regulation in Other Countries We are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of: • design, development, manufacturing and testing (including with respect to significant changes to the products); • product standards; • product safety; • product safety reporting; • marketing, sales and distribution; • packaging and storage requirements; • labeling requirements; • content and language of instructions for use; • clinical trials/investigations; • record keeping procedures; • advertising and promotion; • recalls and field corrective actions; • post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; • import and export restrictions; • tariff regulations, duties and tax requirements; • registration for reimbursement, agreement of prices with government; and • necessity of testing performed in country by distributors for licensees.
Regulation in Other Countries We are subject to regulations and product registration requirements in many foreign countries in which we may sell our products, including in the areas of: • design, development, manufacturing and testing (including with respect to significant changes to the products); • product standards; • product safety; • product safety reporting; • marketing, sales and distribution; • packaging and storage requirements; • labeling requirements; • content and language of instructions for use; • clinical trials/investigations; • record keeping procedures; • advertising and promotion; • recalls and field corrective actions; • post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; • import and export restrictions; • tariff regulations, duties and tax requirements; • registration for reimbursement, agreement of prices with government; and • necessity of testing performed in country by distributors for licensees.
Our regulatory function includes a team with both U.S. and international medical device regulatory expertise and is supported by senior FDA regulatory advisors and outside legal counsel. For the years ended December 31, 2024, 2023 and 2022 our research, development and clinical trials expenses were $56.0 million, $36.1 million and $26.8 million, respectively.
Finally, our regulatory function includes a team with both U.S. and international medical device regulatory expertise and is supported by senior ex-FDA regulatory advisors and outside legal counsel. For the years ended December 31, 2025, 2024 and 2023 our research, development and clinical trials expenses were $69.1 million, $56.0 million and $36.1 million, respectively.
The MHRA Enforcement of Medical Device Regulations in the UK To ensure that medical devices placed on the market and put into service in the UK meet applicable regulatory requirements the MHRA will: • conduct risk-based assessments of all allegations of non-compliance brought to their attention; • monitor the activity of UK Approved Bodies designated by MHRA to assess the compliance of manufacturers; and • investigate medical devices as a result of adverse incident reports or intelligence indicating a potential problem.
The advertising and marketing of medical devices is governed in the UK primarily by self-regulatory codes of practice. 19 The MHRA Enforcement of Medical Device Regulations in the UK To ensure that medical devices placed on the market and put into service in the UK meet applicable regulatory requirements the MHRA will: • conduct risk-based assessments of all allegations of non-compliance brought to their attention; • monitor the activity of UK Approved Bodies designated by MHRA to assess the compliance of manufacturers; and • investigate medical devices as a result of adverse incident reports or intelligence indicating a potential problem.
The second mechanism involves a separate payment, in addition to the MS-DRG-based payment, for organ acquisition costs, which include organ preservation and transportation costs. Medicare reimburses hospitals for allowable organ acquisition costs on a reasonable cost basis.
The second mechanism involves a separate payment, in addition to the MS-DRG-based payment, for organ acquisition costs, which include organ preservation and transportation costs. Medicare reimburses hospitals for allowable organ acquisition costs on a reasonable cost basis. The OCS is reimbursed under this second mechanism.
As of December 31, 2024, we employed 728 people globally, most of whom were full-time employees. Our Culture We strive to foster a global, engaging, and safe work environment where employees want to grow their careers. Our workforce consists of individuals from countries all over the world, representing many different faiths, languages, backgrounds, and cultures.
As of December 31, 2025, we employed 898 people globally, most of whom were full-time and located in the United States. Our Culture We strive to foster a global, engaging, and safe work environment where employees want to grow their careers. Our workforce consists of individuals from countries all over the world, representing many different faiths, languages, backgrounds, and cultures.
Each employee is provided formal written feedback, at least annually, and together with his/her manager, develops individual goals that are derived from our overall corporate and financial goals. Moreover, we collaborate with our employees to provide customized career development plans as well as general and targeted training curricula based on their roles.
Employees are provided with formal written feedback, at least annually, and together with their manager, develop individual goals that are derived from our overall corporate and financial goals. Moreover, we collaborate with our employees to provide customized career development plans as well as general and targeted training curricula based on their roles.
Issued patents in our portfolio are expected to expire between 2025 and 2038, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.
Issued patents in our portfolio are expected to expire between 2026 and 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.
Since its inception in 2021, the NOP has accelerated adoption of the OCS, and we believe this program has the potential to maximize utilization of donor organs for transplantation and, by standardizing the quality of use of the OCS, deliver better clinical outcomes. • Develop the next generation OCS technology platform to improve user experience and facilitate our NOP.
Since its inception in 2021, the NOP has accelerated adoption of the OCS, and we believe this program has the potential to maximize utilization of donor organs for transplantation and, by standardizing the quality of use of the OCS, deliver better clinical outcomes. • Develop the next generation and Gen-3 OCS technology platforms, including expansion into additional organs, to improve user experience and facilitate our NOP.
Research, Development and Clinical Trial Operations Our research, development and clinical trial operations function consists of a dedicated clinical trial team that has trial management, data collection and biostatistics expertise. Our product engineering function consists of multi-disciplinary engineering teams that have electrical, mechanical, systems and software engineering expertise.
The function includes a dedicated clinical trial team that has trial management, data collection and biostatistics expertise. Additionally, our product engineering function consists of multi-disciplinary engineering teams that have electrical, mechanical, systems and software engineering expertise.
The OCS Perfusion Set includes all accessories needed to place the organ on the system. • OCS Solutions: The OCS Solutions are a set of nutrient-enriched solutions used with blood to replenish depleted nutrients and hormones needed to optimize the organ’s condition outside of the human body. 6 The OCS technology platform is equipped with the following core technologies that we designed to comprehensively address the limitations of cold storage and improve transplant outcomes: • proprietary pulsatile blood pump to simulate beating heart perfusion in organs outside of the human body; • proprietary software-controlled titanium blood warmer to maintain blood at body temperature while maximizing portability; • gas exchanger to maintain organ oxygenation outside of the human body; • customized hemodynamics sensors to monitor and assess organ function outside of the human body; • proprietary software-controlled, miniaturized, electromechanical system with universal power supply and hot-swappable batteries to maximize portability and travel distance for organ procurement; • proprietary wireless monitor and control software to provide an intuitive user interface for monitoring critical organ function; and • customized carbon fiber OCS console structure to reduce the overall weight of the system and maximize portability.
The OCS technology platform is equipped with the following core technologies that we designed to comprehensively address the limitations of cold storage and improve transplant outcomes: • proprietary pulsatile blood pump to simulate beating heart perfusion in organs outside of the human body; • proprietary software-controlled titanium blood warmer to maintain blood at body temperature while maximizing portability; 6 • gas exchanger to maintain organ oxygenation outside of the human body; • customized hemodynamics sensors to monitor and assess organ function outside of the human body; • proprietary software-controlled, miniaturized, electromechanical system with universal power supply and hot-swappable batteries to maximize portability and travel distance for organ procurement; • proprietary wireless monitor and control software to provide an intuitive user interface for monitoring critical organ function; and • customized carbon fiber OCS console structure to reduce the overall weight of the system and maximize portability.
We are developing the next generation multi-organ platform to improve the usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.
In addition, we are developing the Gen-3 multi-organ platform to improve the OCS usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.
Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and offers the potential to significantly improve donor organ utilization.
Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and reported high donor organ utilization rates for transplants.
This team is focused on the following research, development and clinical trial activities: • developing the next generation OCS; • developing applications to expand the access and use of the data generated from the OCS; • expanding the body of clinical evidence supporting the use of the OCS platform through pre-market clinical trials, post-market registries and scientific publications; • improving incrementally the technology and manufacturing efficiency of our current platform; and 12 • conducting research to investigate new clinical applications and uses for the OCS platform.
Research, Development and Clinical Trial Operations Our research, development and clinical trial operations function is focused on developing the next generation and Gen-3 OCS, including development of OCS products for additional organs; improving incrementally the technology and manufacturing efficiency of our current platform; expanding the body of clinical evidence supporting the use of the OCS platform through pre-market clinical trials, post-market registries and scientific publications; developing applications to expand the access and use of the data generated from the OCS; and conducting research to investigate new clinical applications and uses for the OCS platform.
As of December 31, 2024, we had 728 employees, most of whom were full-time and located in the United States. We generated $441.5 million, $241.6 million and $93.5 million of total revenue during the years ended December 31, 2024, 2023 and 2022, respectively, representing year-over-year growth of 82.7% and 158.5% in 2024 and 2023, respectively.
As of December 31, 2025, we had a total of 898 employees worldwide, most of whom were full-time and located in the United States. We generated $605.5 million, $441.5 million and $241.6 million of total revenue during the years ended December 31, 2025, 2024 and 2023, respectively, representing year-over-year growth of 37.1% and 82.7% in 2025 and 2024, respectively.
These requirements include that the manufacturer must report to the relevant national competent authorities any serious incident involving devices made available on the market and any field safety corrective action in respect of devices made available on the market or undertaken in a third country in relation to a device made available on the market.
These requirements include that the manufacturer must report to the relevant national competent authorities (a) any serious incident involving devices made available on the EU market and (b) any field safety corrective action (i) in respect of devices made available on the EU market or (ii) undertaken in a third country in relation to a device made available on the EU market if the reason for such action is not limited to the device made available in the third country.
Despite the MDR not applying in Great Britain, the UK MDR provides a transitional period that allows manufacturers to place devices CE marked under the MDR (including their relevant transition periods), on the market in Great Britain potentially up until June 30, 2030, depending on the class of device.
Despite the MDR not applying in Great Britain, the UK MDR provides a transitional period that allows manufacturers to place devices CE marked under the MDR on the market in Great Britain potentially up until June 30, 2030.
This patent and any patents issued from pending patent applications are expected to expire in 2035, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. We have requested patent term extension for one patent relating to the OCS Liver, U.S. Patent No. 10,076,112, which, if granted, would expire in 2035.
This patent and any patents issued from pending patent applications are expected to expire in 2035, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. Patent term extension for one patent relating to the OCS Liver, U.S.
Certain other changes to an approved device require the submission and approval of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.
Certain other changes to an approved device require the submission and approval of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness. 15 Clinical Trials Clinical trials are almost always required to support a PMA application and may be necessary to support PMA supplements for additional indications or modified versions of a marketed device product.
We utilize two assembly shifts and we have the ability to add additional shifts to the cleanroom to further increase production capacity. We manufacture our sterilized disposable OCS Perfusion Sets in an ISO class 7 cleanroom.
Manufacturing and Supply Chain Operations We design and assemble our OCS Consoles and disposable OCS Perfusion Sets at our facility in Andover, Massachusetts. We utilize two assembly shifts and we have the ability to add additional shifts to the cleanroom to further increase production capacity. We manufacture our sterilized disposable OCS Perfusion Sets in an ISO class 7 cleanroom.
Since 2023, we have offered logistics services through our NOP, including aviation transportation, ground transportation, and other coordination activity that is capable of arranging procurement missions on limited notice and at various hours of the day.
Our transplant logistics services include aviation transportation, ground transportation, and other coordination activity that is capable of arranging procurement missions on limited notice and at various hours of the day.
These include: • a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market; • all medical devices, including in vitro diagnostic medical devices, or IVDs, custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market; • medical device manufacturers based outside the UK who wish to place a device on the Great Britain market need to appoint a single UK Responsible Person for all devices who will act on their behalf to carry out specified tasks, such as registration.
These include: • a Great Britain-specific pathway to market which involves product marking with the UKCA mark, potentially involving a UK Approved Body, depending on the class of device; • an obligation to register all medical devices, including in vitro diagnostic medical devices, or IVDs, custom-made devices and systems or procedure packs, with the MHRA before they are placed on the Great Britain market; and • an obligation on medical device manufacturers based outside the UK who wish to place a device on the Great Britain market to appoint a single UK Responsible Person for all devices who will act on their behalf to carry out specified tasks, such as registration.
These patents, and any patents issued from pending patent applications, are expected to expire in 2038, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. We have requested patent term extension for one patent relating to the OCS Heart, U.S. Patent No. 7,651,835, which, if granted, would expire in 2032.
These patents, and any patents issued from pending patent applications, are expected to expire in 2039, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. Patent term extension for one patent relating to the OCS Heart, U.S.
Cold storage is a rudimentary approach to organ preservation in which a donor organ is flushed with cold pharmaceutical solutions, placed in a plastic bag on top of ice and transported in a cooler.
Cold storage is a rudimentary approach to organ preservation in which a donor organ is flushed with cold pharmaceutical solutions, placed in a plastic bag on top of ice and transported in a cooler. Cold storage subjects organs to significant injury due to a lack of oxygenated blood supply, or ischemia.
Since January 1, 2021 (when the Brexit transition period ended), there have been a number of changes, introduced through secondary legislation, on how medical devices are placed on the market in Great Britain (England, Wales and Scotland).
Since January 1, 2021 (when the Brexit transition period ended), there have been a number of changes, introduced to the UK MDRs, which regulate how medical devices are placed on the market in Great Britain.
Our corporate headquarters, manufacturing and clinical training facilities are located in Andover, Massachusetts. We also have a geographically distributed team in the United States supporting our NOP and a designated maintenance hub for our aircraft in Dallas, Texas. We have additional distribution and commercial operations in Europe.
We also have a geographically distributed team in the United States supporting our NOP and a designated maintenance hub for our aircraft in Dallas, Texas. We have additional distribution, commercial and research and development operations in Europe.
Under the EU-US DPF, it is possible to transfer EEA personal data freely to the US recipient that has self-certified under the EU-US DPF regime, although this may be challenged in the European Union Court of Justice by EU based privacy advocates.
Under the EU-US DPF, it is possible to transfer EEA personal data freely to the US recipient that has self-certified under the EU-US DPF regime, although this may be challenged in the European Union Court of Justice by EU based privacy advocates. 23 We are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject to applicable law.
The Medicare program and private payors had been providing reimbursement for the OCS Lung, OCS Heart and OCS Liver during the U.S. pivotal trials and have continued providing reimbursement for our products and services following FDA approval. We are in the process of seeking long-term reimbursement for our products outside of the United States.
Our OCS products and NOP services are reimbursed in the United States through existing, standard commercial transplant billing mechanisms. The Medicare program and private payors had been providing reimbursement for the OCS Lung, OCS Heart and OCS Liver during the U.S. pivotal trials and have continued providing reimbursement for our products and services following FDA approval.
If satisfied that the relevant medical device conforms to the relevant GSPRs, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.
Notified bodies are independent organizations which audit and examine a product’s technical dossier and the manufacturer's quality system. If satisfied that the relevant medical device conforms to the relevant GSPRs, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.
The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK. The MHRA is also responsible for the designation and monitoring of UK approved bodies (the equivalent of EU notified bodies).
The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK.
As of December 31, 2024, our patent portfolio relating to the OCS Solutions or other solutions for transplantation systems includes families comprised of patents and patent applications with claims that are generally directed to compositions of certain perfusion fluids.
Patent No. 10,076,112, was granted on June 24, 2025, extending the patent term to expire on September 28, 2035. As of December 31, 2025, our patent portfolio relating to the OCS Solutions or other solutions for transplantation systems includes families comprised of patents and patent applications with claims that are generally directed to compositions of certain perfusion fluids.
In the EEA, as well as in the United Kingdom, or the UK, -post-Brexit, we may be subject to laws relating to our collection, control, processing and other use of personal data, such as data relating to an identified or identifiable living individual.
Some states have also passed further protections focused on data protection for health information, including the Washington My Health My Data Act. 22 In the EEA, as well as in the United Kingdom, or the UK, -post-Brexit, we may be subject to laws relating to our collection, control, processing and other use of personal data, such as data relating to an identified or identifiable living individual.
Since May 26, 2021, the MDR has applied throughout EU and Northern Ireland. As the MDR took effect after the UK left the European Union, it was not retained and therefore does not apply in Great Britain (England, Wales and Scotland).
As the MDR took effect after the UK left the European Union, it was not retained in UK law and therefore does not apply in Great Britain (England, Wales and Scotland). It applies in Northern Ireland under the terms of the Northern Ireland Protocol.
Cold storage subjects organs to significant injury due to a lack of oxygenated blood supply, or ischemia, does not allow physicians to assess organ viability and lacks the ability to optimize an organ’s condition once it has been retrieved from the donor.
Further, cold storage does not allow physicians to assess organ viability and lacks the ability to optimize an organ’s condition once it has been retrieved from the donor.
For each OCS product, we supplement the platform with organ-specific, customized and proprietary technologies. To date, we have developed three OCS products, one for each of lung, heart and liver transplantation. We have initiated the development of the next generation multi-organ platform to improve the usability, incorporate new technology and automation, and facilitate the use of OCS in our NOP.
For each OCS product, we supplement the platform with organ-specific, customized and proprietary technologies. To date, we have developed three OCS products, one for each of lung, heart and liver transplantation.
Some states establish a global payment for the transplant and organ acquisition costs, and some states have separate payments for the inpatient stay based on the MS-DRG system and for organ acquisition costs.
For Medicaid transplant recipients, reimbursement to a transplant hospital for the incurred cost of the OCS is determined based on the applicable state Medicaid program. Some states establish a global payment for the transplant and organ acquisition costs, and some states have separate payments for the inpatient stay based on the MS-DRG system and for organ acquisition costs.
The manufacturer must also ensure their device meets appropriate standards of safety and performance for as long as it is in use. The advertising and marketing of medical devices is governed in the UK by both legislation and self-regulatory codes of practice.
The manufacturer must also ensure their device meets appropriate standards of safety and performance for as long as it is in use.
Our patent portfolio includes patents and patent applications that we own or license from third parties. As of December 31, 2024, our owned and licensed patent portfolio consisted of approximately 430 issued patents and pending patent applications worldwide, including in the United States, Australia, Europe, Canada, China, Israel, New Zealand and Japan.
As of December 31, 2025, our owned and licensed patent portfolio consisted of approximately 451 issued patents and pending patent applications worldwide, including in the United States, Australia, Europe, Canada, China, Israel, New Zealand and Japan. Our owned portfolio includes patents and applications related to one or more of the OCS Lung, OCS Heart, OCS Liver and solutions.
Compensation and Benefits: We offer competitive compensation and benefits in an exciting, demanding, and fast-paced work environment. We provide employee benefits to eligible employees to promote personal health and well-being and to provide certain financial security and protection upon retirement or in the event of death, disability or illness.
We provide employee benefits to eligible employees to promote personal health and well-being and to provide certain financial security and protection upon retirement or in the event of death, disability or illness. Career Development: We are proud to have a work environment that promotes continued development for our employees.
In addition, we believe the increase in transplant volumes enabled by the OCS will help providers achieve “Center of Excellence” designations with payors and thus drive significant revenue growth for their transplant programs. 7 Value to Payors We believe organ transplantation is a cost-effective treatment for end-stage organ failure as it provides the longest life expectancy, and better quality of life, compared to other treatments like mechanical support or medical therapy.
Value to Payors We believe organ transplantation is a cost-effective treatment for end-stage organ failure as it provides the longest life expectancy, and better quality of life, compared to other treatments like mechanical support or medical therapy.
Clinical investigations for medical devices cannot proceed without a positive opinion of an ethics committee and notification to the relevant national competent authorities.
Clinical investigations for medical devices cannot proceed without a positive opinion of an ethics committee and notification to the relevant national competent authorities. Both national competent authorities and ethics committees also require the submission of serious adverse event reports during a study and may request a copy of the final study report.
The authorization/approval processes for devices outside the European Union will vary from country to country and the time may be longer or shorter than that required for FDA clearance or approval or CE marking. 13 FDA Premarket Clearance and Approval Requirements Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a PMA or issuance of a de novo classification order.
FDA Premarket Clearance and Approval Requirements Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a PMA or issuance of a de novo classification order.
For example, we may be subject to the GDPR (or UK GDPR) even when processing personal data in connection with offering goods or services to persons located in the EEA (or UK) or monitoring the behavior of persons located in the EEA (or UK). 22 GDPR requirements include that personal data may only be collected for specified, explicit and legitimate purposes based on a certain legal bases set forth in GDPR, and may only be processed in a manner consistent with those purposes.
GDPR requirements include that personal data may only be collected for specified, explicit and legitimate purposes based on a certain legal bases set forth in GDPR, and may only be processed in a manner consistent with those purposes.
Our Strategy We are committed to our goal of transforming organ transplantation with our OCS platform by establishing the OCS as the standard of care for solid organ transplantation and thereby increasing the utilization of donor organs and improving clinical outcomes.
We believe the OCS will enable payors to benefit from these favorable health economics and limit their exposure to the high cost of severe post-transplantation complications and extended hospital stays. 7 Our Strategy We are committed to our goal of transforming organ transplantation with our OCS platform by establishing the OCS as the standard of care for solid organ transplantation and thereby increasing the utilization of donor organs and improving clinical outcomes.
We have begun to add resources in Europe focused on commercial expansion and market access. We believe international expansion will be an additional growth driver for us in the long-term. Commercialization We commercialize our products through two channels: our NOP and a direct acquisition model.
We believe international expansion could represent an additional growth driver for us in the long-term. We have begun to add resources in Europe focused on commercial expansion and market access, including the introduction of NOP in certain regions.
We are aware of only two other companies providing warm perfusion systems, OrganOx Limited and XVIVO Perfusion AB, both of which offer single-organ warm perfusion systems for the liver and lung, respectively. We also compete with other cold preservation devices in this industry, such as those from Paragonix Tecchnologies, Inc. Paragonix Technologies was acquired by Getinge in September 2024.
We are aware of only two other companies providing warm perfusion systems, OrganOx Limited, which was acquired by Terumo Corporation in October 2025, and XVIVO Perfusion AB, both of which offer single-organ warm perfusion systems for the liver and lung, respectively.
Furthermore, numerous U.S. and foreign issued patents and patent applications owned by third parties exist in the fields in which we are developing products.
Notwithstanding the scope of the patent protection available to us, a competitor could develop methods or devices that are not covered by our patents. Furthermore, numerous U.S. and foreign issued patents and patent applications owned by third parties exist in the fields in which we are developing products.
We aim to hire people with the right skill sets, growth mindset, and work ethic to drive business results and help us achieve our goals. We provide relocation benefits to eligible employees whom we request to move in connection with their employment with the objective of attracting and deploying top talent.
We aim to hire people with the right skill sets, growth mindset, and work ethic to drive business results and help us achieve our goals.
We are subject to the supervision of local data protection authorities in those jurisdictions where we are established or otherwise subject to applicable law. We depend on third parties in relation to provision of our services, a number of which process personal data on our behalf.
We depend on third parties in relation to provision of our services, a number of which process personal data on our behalf.
In 2025, we expect the initial next generation OCS improvements in the OCS Lung and OCS Heart products to be introduced to the clinical setting through the enrollment of several new clinical trials. • Expand internationally by accessing national reimbursement for OCS in key European countries.
In 2025, we introduced next generation OCS improvements in the clinical setting for OCS Lung and OCS Heart through the enrollment of two new clinical trials.
We source many of the components for the OCS Console and OCS Perfusion Sets from third-party suppliers that are required to manufacture and test them according to our specifications. We purchase some of the components of the OCS Console and OCS Perfusion Set from single-source suppliers and, in a few cases, sole-source suppliers.
We purchase some of the components of the OCS Console and OCS Perfusion Set from single-source suppliers and, in a few cases, sole-source suppliers. We source the OCS Solutions using our proprietary formulas from third-party suppliers. Fresenius is our single-source supplier of OCS Solutions for the OCS Lung and OCS Heart.
In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ manufacturing facility or facilities to ensure compliance with the QSR and, in some cases, will audit the applicant and clinical sites as part of its Bioresearch Monitoring program. 14 During the PMA review, the FDA assesses whether the data and information in the PMA constitute valid scientific evidence to support a determination that there is a reasonable assurance that the device is safe and effective for its intended use(s) based on the proposed labeling.
During the PMA review, the FDA assesses whether the data and information in the PMA constitute valid scientific evidence to support a determination that there is a reasonable assurance that the device is safe and effective for its intended use(s) based on the proposed labeling.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe timing and amount of our operating and capital expenditures will depend on many factors, including: • revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions; • the costs and expenses of expanding our U.S. and non-U.S. commercial infrastructure and our manufacturing operations; 27 • the extent to which our OCS products are adopted by the transplant community; • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products; • the costs incurred in our efforts to operate and grow our NOP, including the costs and timing of growing our logistics capabilities, inclusive of acquiring and maintaining current and additional aircraft for our aviation transportation services; • the costs and timing of research and development of the next generation of OCS products; • the degree of success we experience in commercializing our OCS products for additional indications; • the costs, timing and outcomes of any future clinical studies and regulatory reviews, including to seek and obtain approvals for the next generation of OCS products or for new indications for our OCS products; • the emergence of competing or complementary technologies; • the number and types of future products we develop and commercialize; • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and • the level of our selling, general and administrative expenses.
Biggest changeThe timing and amount of our operating and capital expenditures will depend on many factors, including: • revenue generated from our NOP services and sales of our OCS Consoles, OCS Perfusion Sets and OCS Solutions and other products that may be approved in the United States and select non-U.S. markets; • the costs and expenses of expanding our U.S. and non-U.S. commercial infrastructure and our manufacturing operations; 27 • the extent to which our OCS products are adopted by the transplant community; • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products; • the costs associated with maintaining and growing our transplant logistics capabilities, including by means of attracting, training and retaining pilots, and the acquisition, maintenance, or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments; • the costs and timing of research and development of the next generation of OCS products; • the degree of success we experience in commercializing our OCS products for additional indications; • the costs, timing and outcomes of pre- and post-approval studies and any future clinical studies and regulatory reviews, including to seek and obtain approvals for the next generation of OCS products or for new indications for our OCS products; • the emergence of competing or complementary technologies; • the number and types of future products we develop and commercialize; • the cost of constructing research and development and manufacturing facilities in Italy; • the costs related to establishing and relocating to a new long-term global headquarters to accommodate the growing scale and complexity of our business; • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and • the level of our selling, general and administrative expenses.
Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or if we will be able to maintain profitability. Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to limitations.
Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or if we will be able to maintain profitability. Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to future limitations.
Examples of such laws include: the FCPA, Bribery Act and the GDPR. The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state.
Examples of such laws include: the FCPA, the Bribery Act and the GDPR. The extra-territorial effect of those laws affects our sales and marketing strategy, since in many countries healthcare professionals are officers of the state.
Failure by our sales staff to comply with those laws may result in criminal and civil penalties and damage our reputation; and 56 • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any private payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, including the GDPR, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
Failure by our sales staff to comply with those laws may result in criminal and civil penalties and damage our reputation; and • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any private payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers; foreign and state laws, including the GDPR, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: 45 • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect the OCS; • any of our pending patent applications will issue as patents; • we will be able to successfully commercialize our products on a substantial scale, if approved, before any relevant patents we may have expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; any of our patents will be found to ultimately be valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; • we will develop additional proprietary technologies or products that are separately patentable; or • our commercial activities or products will not infringe upon the patents of others.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect the OCS; • any of our pending patent applications will issue as patents; • we will be able to successfully commercialize our products on a substantial scale, if approved, before any relevant patents we may have expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; • any of our patents will be found to ultimately be valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; • we will develop additional proprietary technologies or products that are separately patentable; or • our commercial activities or products will not infringe upon the patents of others.
The success of any new product offering or product enhancements to our OCS platform will depend on several factors, including our ability to: • properly identify and anticipate surgeon and patient needs; • develop and introduce new products and product modifications in a timely manner; • avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties; • demonstrate the safety and efficacy of new products and product modifications; • obtain necessary regulatory clearances or approvals; • comply with regulations regarding the marketing of new products or product modifications; 29 • provide adequate training to potential users of our products; • receive adequate coverage and reimbursement for procedures performed with our products; and • develop an effective commercialization effort.
The success of any new product offering or product enhancements to our OCS platform will depend on several factors, including our ability to: • properly identify and anticipate surgeon and patient needs; • develop and introduce new products and product modifications in a timely manner; • avoid infringing upon, misappropriating or otherwise violating the intellectual property rights of third parties; • demonstrate the safety and efficacy of new products and product modifications; • obtain necessary regulatory clearances or approvals; • comply with regulations regarding the marketing of new products or product modifications; • provide adequate training to potential users of our products; • receive adequate coverage and reimbursement for procedures performed with our products; and • develop an effective commercialization effort.
Alternatively, if the Business 61 Litigation Session of the Superior Court of Suffolk County, Massachusetts or a court outside of Massachusetts were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other venues or jurisdictions, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
Alternatively, if the Business Litigation Session of the Superior Court of Suffolk County, Massachusetts or a court outside of Massachusetts were to find this exclusive forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other venues or jurisdictions, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
Conversely, if we underestimate customer demand for our products or our own requirements for components, subassemblies and materials, our manufacturing partners and suppliers may not be able to deliver components, sub-assemblies and materials to meet our requirements and our manufacturing may be affected by the impact of inflation and labor shortages on our suppliers, which could result in inadequate inventory levels or interruptions, delays or cancellations of deliveries to our customers, any of which would damage our reputation, customer relationships and business.
Conversely, if we underestimate customer demand for our products or our own requirements 30 for components, subassemblies and materials, our manufacturing partners and suppliers may not be able to deliver components, sub-assemblies and materials to meet our requirements and our manufacturing may be affected by the impact of inflation and labor shortages on our suppliers, which could result in inadequate inventory levels or interruptions, delays or cancellations of deliveries to our customers, any of which would damage our reputation, customer relationships and business.
Some of the factors that may cause the market price of our common stock to fluctuate include: • price and volume fluctuations in the overall stock market; • volatility in the market price and trading volume of comparable companies; • actual or anticipated changes in our earnings or fluctuations in our operating results or in the expectations of securities analysts; • results of post-approval studies or clinical trials relating to next generation products for the OCS or competing products; • failure or discontinuation of any of our product development and research programs; • regulatory or legal developments in the United States and other countries, including changes in the healthcare payment systems; • results or changes in the status of, or developments relating to, applications for regulatory approvals or clearances for the OCS or competing products; • our announcements or our competitors’ announcements of new products, procedures or therapies; • departure of key personnel; • litigation involving us or that may be perceived as having an adverse effect on our business; 60 • developments or disputes concerning patent applications, issued patents or other proprietary rights; • market conditions in the medical device and biotechnology sectors; • changes in general economic, industry and market conditions and trends; • investors’ general perception of us; and • sales of large blocks of our stock.
Some of the factors that may cause the market price of our common stock to fluctuate include: • price and volume fluctuations in the overall stock market; • volatility in the market price and trading volume of comparable companies; • actual or anticipated changes in our earnings or fluctuations in our operating results or in the expectations of securities analysts; • results of post-approval studies or clinical trials relating to next generation products for the OCS or competing products; • failure or discontinuation of any of our product development and research programs; • regulatory or legal developments in the United States and other countries, including changes in the healthcare payment systems; • results or changes in the status of, or developments relating to, applications for regulatory approvals or clearances for the OCS or competing products; • our announcements or our competitors’ announcements of new products, procedures or therapies; 58 • departure of key personnel; • litigation involving us or that may be perceived as having an adverse effect on our business; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • market conditions in the medical device and biotechnology sectors; • changes in general economic, industry and market conditions and trends; • investors’ general perception of us; and • sales of large blocks of our stock.
Inadequate funding for the FDA, SEC or other government agencies could impact the timeliness of responses or action and may slow the time necessary for agency reviews, which in turn would have a material adverse effect on our business, financial condition and results of operations In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs and improve access to transplantation.
Inadequate funding for the FDA or other government agencies could impact the timeliness of responses or action and may slow the time necessary for agency reviews, which in turn would have a material adverse effect on our business, financial condition and results of operations In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs and improve access to transplantation.
The following could adversely affect the costs, timing or successful completion of any clinical trial: • we have been required and, prior to collecting clinical data in the future to support new PMA applications, may be required again to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials, and the FDA may reject our IDE application and notify us that we may not begin investigational trials; • regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials; 35 • regulators and/or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; • we may not reach agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different trial sites; • clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • the number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; • our third-party contractors, including those manufacturing or sterilizing our products, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all; • we might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; • we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for re-examination; • regulators, IRBs or other reviewing bodies may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements; • the cost of clinical trials may be greater than we anticipate; • we may be unable to recruit a sufficient number of clinical trial sites; • regulators or other reviewing bodies may fail to accept as satisfactory, fail to approve, or subsequently find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; • approval policies or regulations of FDA or applicable foreign regulatory agencies may change in a manner rendering our clinical data insufficient for approval; and • our current or future products may have undesirable side effects or other unexpected characteristics.
The following could adversely affect the costs, timing or successful completion of any clinical trial: • we have been required and, prior to collecting clinical data in the future to support new PMA applications, may be required again to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials, and the FDA may reject our IDE application and notify us that we may not begin investigational trials; • regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials; • regulators and/or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; • we may not reach agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different trial sites; • clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; • the number of subjects or patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; • our third-party contractors, including those manufacturing or sterilizing our products, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all; • we might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; • we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for re-examination; • regulators, IRBs or other reviewing bodies may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements; • the cost of clinical trials may be greater than we anticipate; • we may be unable to recruit a sufficient number of clinical trial sites; • regulators or other reviewing bodies may fail to accept as satisfactory, fail to approve, or subsequently find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; • approval policies or regulations of FDA or applicable foreign regulatory agencies may change in a manner rendering our clinical data insufficient for approval; and • our current or future products may have undesirable side effects or other unexpected characteristics. 35 Failure can occur at any stage of clinical testing.
Our failure to comply with applicable regulatory requirements could result in enforcement actions by the FDA or state agencies, which may include any of the following sanctions: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • recall, suspension or termination of distribution, administrative detention, injunction or seizure of organ-specific OCS Consoles or disposable sets; • customer notifications or repair, replacement or refunds; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for premarket approval of new products or for modifications to existing products, and refusing or delaying our requests for PMAs for new intended uses of the OCS; • withdrawing or suspending PMA approvals that have already been granted, resulting in prohibitions on sales of our products; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and • criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement actions by the FDA or state agencies, which may include any of the following sanctions: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • recall, suspension or termination of distribution, administrative detention, injunction or seizure of organ-specific OCS Consoles or disposable sets; • customer notifications or repair, replacement or refunds; • operating restrictions or partial suspension or total shutdown of production; • refusing or delaying our requests for PMA of new products or for modifications to existing products, and refusing or delaying our requests for PMAs for new intended uses of the OCS; • withdrawing or suspending PMA approvals that have already been granted, resulting in prohibitions on sales of our products; • FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and • criminal prosecution.
We have limited experience operating aircraft, and we continue to depend on certain members of the former management team of Summit and additional employees we may hire for the successful operation of aviation transportation services and the integration into our NOP services offering. We must comply with applicable laws and regulations to manage our growing NOP logistics network.
We have limited experience operating aircraft, and we continue to depend on certain members of the former management team of Summit and additional employees we may hire for the successful operation of aviation transportation services and the integration into our NOP services offering. We must comply with applicable laws and regulations to manage our growing NOP transplant logistics network.
In addition, our expected growth will require us to hire a significant number of qualified personnel, including clinical development, regulatory, sales, marketing, engineering, scientific, clinical, logistics and aviation support and administrative personnel. There is intense competition from other companies and research and academic institutions for qualified personnel in the areas of our activities.
In addition, our expected growth will require us to hire a significant number of qualified personnel, including clinical development, regulatory, sales, marketing, engineering, scientific, clinical, logistics and aviation support and administrative personnel. There is intense competition from other companies and research and academic institutions for qualified personnel in the 41 areas of our activities.
In addition, we may not be able to affix the CE mark to new or modified products and we may fail to obtain any additional regulatory qualifications, clearances or approvals or to comply with additional legal obligations required by the individual member states of the European Union or other countries in which we seek to market the OCS.
In addition, 51 we may not be able to affix the CE mark to new or modified products and we may fail to obtain any additional regulatory qualifications, clearances or approvals or to comply with additional legal obligations required by the individual member states of the European Union or other countries in which we seek to market the OCS.
Failure to perform timely maintenance and repairs results in aircraft being underutilized which could have an adverse impact on our business, financial condition and results of operations. On occasion, airframe manufacturers and/or regulatory authorities require mandatory or recommended modifications across a particular fleet which may ground a particular type of aircraft.
Failure to perform timely maintenance and repairs results in aircraft being underutilized which could have an adverse impact on our business, financial condition and results of operations. On occasion, airframe manufacturers and/or regulatory authorities require mandatory or 37 recommended modifications across a particular fleet which may ground a particular type of aircraft.
We may not be able to pass along increased component part prices to customers in the form of price increases or our ability to do so could be delayed. Consequently, our results of operations and financial condition may be adversely affected. 34 Our failure to compete effectively will harm our business and operating results.
We may not be able to pass along increased component part prices to customers in the form of price increases or our ability to do so could be delayed. Consequently, our results of operations and financial condition may be adversely affected. Our failure to compete effectively will harm our business and operating results.
Issues can arise in any number of circumstances, including employment-related offenses such as workplace harassment and discrimination, regulatory noncompliance, failure to properly use and protect data and systems, and violations of our employee policies, as well as from actions taken by regulators or others in response to such conduct.
Issues can arise in any number of circumstances, including employment-related offenses such as workplace harassment and discrimination, regulatory noncompliance, failure to properly use and protect data and systems, and violations of our employee policies, as well as from actions taken by regulators or 39 others in response to such conduct.
We will need to continue to monitor the developments in the UK to assess how they impact our devices sold in Great Britain. 55 We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties.
We will need to continue to monitor the developments in the UK to assess how they impact our devices sold in Great Britain. We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties.
We may be unable to transition to alternative methods of sterilization in a timely or cost-effective manner or at all, which could harm our business and results of operations. 30 Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
We may be unable to transition to alternative methods of sterilization in a timely or cost-effective manner or at all, which could harm our business and results of operations. Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
When our aircraft are grounded for maintenance, we are required to rely on third-party logistics service providers to transport organs for our NOP, which increases the cost of operating our NOP. 38 We rely on third-party service providers to perform functions integral to our operations, including ground handling, landing fees, fueling, maintenance, and other services.
When our aircraft are grounded for maintenance, we are required to rely on third-party logistics service providers to transport organs for our NOP, which increases the cost of operating our NOP. We rely on third-party service providers to perform functions integral to our operations, including ground handling, landing fees, fueling, maintenance, and other services.
The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.
The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater 43 financial resources.
Pass-through organ acquisition costs include services required for the acquisition of an organ, such as tissue typing, organ preservation, transport of organs, donor evaluation and other acquisition costs. The separate payments for these costs are determined on a reasonable cost basis established through the transplant center’s Medicare cost report.
Pass-through organ acquisition costs include services required for the acquisition of an organ, 49 such as tissue typing, organ preservation, transport of organs, donor evaluation and other acquisition costs. The separate payments for these costs are determined on a reasonable cost basis established through the transplant center’s Medicare cost report.
Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business.
Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. 45 Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks potentially until June 30, 2030 depending on the class of device and subject to certain conditions and depending on the type of device.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided a transitional period under which the UK will recognize EU CE marks under the EU MDR potentially until June 30, 2030 depending on the class of device and subject to certain conditions and depending on the type of device.
We, the FDA or another regulatory authority may suspend or terminate clinical trials. Successful results in early studies do not assure positive results in subsequent clinical trials. The data we collect from our preclinical studies and clinical trials may not be sufficient to support FDA or other regulatory clearance or approval.
We, the FDA or another regulatory authority may suspend or terminate clinical trials. 34 Successful results in early studies do not assure positive results in subsequent clinical trials. The data we collect from our preclinical studies and clinical trials may not be sufficient to support FDA or other regulatory clearance or approval.
Additionally, this exclusive forum provision may limit the ability of our shareholders to bring a claim in a judicial forum that such shareholders find favorable for disputes with us or our directors or officers, which may discourage such lawsuits against us and our directors and officers.
Additionally, this exclusive forum provision may limit the ability of our shareholders to bring a claim in a judicial forum that such shareholders find favorable for disputes with us or 59 our directors or officers, which may discourage such lawsuits against us and our directors and officers.
An important part of our commercialization efforts is to educate transplant center program directors and other surgeons on the relative merits of the OCS. Our success depends, in large part, on effectively marketing and educating program directors and other surgeons about the benefits of the OCS and our NOP.
An important part of our commercialization efforts is to educate transplant center program directors and other surgeons on the relative merits of the OCS. Our success depends, in large part, on effectively marketing and educating program 31 directors and other surgeons about the benefits of the OCS and our NOP.
If we fail to retain certain members of the existing management of Summit, or if we fail to successfully manage our aircraft operations or growing logistics network, our ability to realize the anticipated benefits of the acquisition of Summit or expansion of our NOP may be adversely affected.
If we fail to retain certain members of the existing management of Summit, or if we fail to successfully manage our aircraft operations or growing transplant logistics network, our ability to realize the anticipated benefits of the acquisition of Summit or expansion of our NOP may be adversely affected.
Third parties may seek to develop, manufacture, distribute and sell systems that we believe infringe our proprietary rights, which would compete against the OCS and impair our ability to sell the OCS in jurisdictions in which our proprietary rights are not upheld.
Third parties may seek to develop, manufacture, distribute and sell systems that we believe infringe our proprietary rights, which would compete against the OCS and impair our 52 ability to sell the OCS in jurisdictions in which our proprietary rights are not upheld.
A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects. 47 Risks Related to Government Regulation Even after approval for the OCS, we are subject to continuing regulation by regulatory authorities and entities in the United States and other countries, and if we fail to comply with any of these regulations, our business could suffer.
A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, which could materially and adversely affect our business, financial condition, operating results, cash flows and prospects. 46 Risks Related to Government Regulation Even after approval for the OCS, we are subject to continuing regulation by regulatory authorities and entities in the United States and other countries, and if we fail to comply with any of these regulations, our business could suffer.
Any cybersecurity incident could also impact our brand, harm our reputation and adversely impact our relationship with our customers, employees and stockholders. Economic, political and other risks associated with foreign operations could adversely affect our international sales and our results of operations.
Any cybersecurity incident could also impact our brand, harm our reputation and adversely impact our relationship with our customers, employees and stockholders. 40 Economic, political and other risks associated with foreign operations could adversely affect our international sales and our results of operations.
If we are not able to maintain the necessary regulatory approvals for the OCS, or obtain the necessary regulatory approvals or clearances for future products on a timely basis or at all, our financial condition and results of operations would suffer, possibly materially, and our business might fail. 49 If we fail to maintain the CE mark in the European Union, Northern Ireland and the UKCA mark (as applicable) in Great Britain, we will not be able to commercially sell and market the OCS in the EU or UK.
If we are not able to maintain the necessary regulatory approvals for the OCS, or obtain the necessary regulatory approvals or clearances for future products on a timely basis or at all, our financial condition and results of operations would suffer, possibly materially, and our business might fail. 48 If we fail to maintain the CE mark in the European Union, Northern Ireland and the UKCA mark (as applicable) in Great Britain, we will not be able to commercially sell and market the OCS in the EU or UK.
Even if we are able to utilize the Bridge to Life Assets and fully realize the benefits of our acquisition of Summit, we may not realize the expected 32 benefits of other future transactions.
Even if we are able to utilize the Bridge to Life Assets and fully realize the benefits of our acquisition of Summit, we may not realize the expected benefits of other future transactions.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Long-term Debt” in this Annual Report on Form 10-K. 48 Our products have been and may in the future be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Long-term Debt” in this Annual Report on Form 10-K. 47 Our products have been and may in the future be subject to product recalls that could harm our reputation and could materially and adversely affect our business, financial condition, operating results, cash flows and prospects.
As of December 31, 2024, our outstanding principal balance of long-term debt under our credit agreement with Canadian Imperial Bank of Commerce, or CIBC, was $60.0 million, which we refer to as the CIBC Credit Agreement. Our payment obligations under the CIBC Credit Agreement reduce cash available to fund working capital, capital expenditures, research and development and general corporate needs.
As of December 31, 2025, our outstanding principal balance of long-term debt under our credit agreement with Canadian Imperial Bank of Commerce, or CIBC, was $60.0 million, which we refer to as the CIBC Credit Agreement. Our payment obligations under the CIBC Credit Agreement reduce cash available to fund working capital, capital expenditures, research and development and general corporate needs.
Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol but does not apply in Great Britain (England, Wales and Scotland).
Post-Brexit the MDR applies in Northern Ireland in accordance with the Northern Ireland Protocol 53 but does not apply in Great Britain (England, Wales and Scotland).
Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.
Proceedings challenging our patents could result in either loss of the patent or 44 denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application.
In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices.
In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QMSR. The QMSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of medical devices.
Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Additionally, as a result of these investigations, healthcare companies and healthcare providers may have to agree to additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Our financial results may fluctuate from quarter to quarter due to a number of factors, including the availability of donor organs for transplantation, which is unpredictable and could impact the volume of transplant procedures performed at transplant centers using the OCS and demand for our NOP.
Our financial results may fluctuate from quarter to quarter due to a number of factors, including the availability of donor organs for transplantation and transplant center surgeons, which is unpredictable and could impact the volume of transplant procedures performed at transplant centers using the OCS and demand for our NOP.
If we fail to comply with the FDA’s QSR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the relevant EU competent authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.
If we fail to comply with the FDA’s QSMR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the relevant EU competent authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.
With respect to the patents and patent applications that we own, any patents that have or may issue from our currently issued or pending patent applications would be expected to expire between 2025 and 2043, assuming all required fees are paid.
With respect to the patents and patent applications that we own, any patents that have or may issue from our currently issued or pending patent applications would be expected to expire between 2026 and 2043, assuming all required fees are paid.
Accordingly, our results of operations could be harmed by a variety of factors, including: • changes in a country’s or region’s political or economic conditions; • longer payment cycles of foreign customers and difficulty of collecting receivables in foreign jurisdictions; • different or changing regulatory or insurance practices regarding reimbursement for transplant procedures; • difficulties in developing effective marketing campaigns in unfamiliar foreign countries; • trade protection measures, import or export licensing requirements or customs clearance and shipping delays; • fluctuations in foreign currency exchange rates; • differing tax laws and changes in those laws in the countries in which we are subject to tax, or potentially adverse tax consequences, including the complexities of foreign value-added tax systems, tax inefficiencies related to our corporate structure, and restrictions on the repatriation of earnings; • changes in international legislation or regulations governing the approval or clearance process for the OCS or ongoing compliance requirements; • differing business practices associated with foreign operations; • difficulties in staffing and managing our international operations; • political, social, and economic instability abroad, terrorist attacks, and security concerns in general; • the burdens of complying with a wide variety of foreign laws and different legal standards, such as anti-bribery laws, including the FCPA, and UK Bribery Act of 2010, or the Bribery Act, data privacy requirements, labor laws and anti-competition regulations; • differing protection of intellectual property; and • increased financial accounting and reporting burdens and complexities. 42 We rely on shipping providers to deliver products to our customers globally.
Accordingly, our results of operations could be harmed by a variety of factors, including: • changes in a country’s or region’s political or economic conditions; • longer payment cycles of foreign customers and difficulty of collecting receivables in foreign jurisdictions; • different or changing regulatory or insurance practices regarding reimbursement for transplant procedures; • difficulties in developing effective marketing campaigns in unfamiliar foreign countries; • trade protection measures, import or export licensing requirements or customs clearance and shipping delays; • fluctuations in foreign currency exchange rates; • differing tax laws and changes in those laws in the countries in which we are subject to tax, or potentially adverse tax consequences, including the complexities of foreign value-added tax systems, tax inefficiencies related to our corporate structure, and restrictions on the repatriation of earnings; • changes in international legislation or regulations governing the approval or clearance process for the OCS or ongoing compliance requirements; • differing business practices associated with foreign operations; • difficulties in staffing and managing our international operations; • political, social, and economic instability abroad, terrorist attacks, and security concerns in general; • the burdens of complying with a wide variety of foreign laws and different legal standards, such as anti-bribery laws, including the FCPA, and the Bribery Act, data privacy requirements, labor laws and anti-competition regulations; • differing protection of intellectual property; and • increased financial accounting and reporting burdens and complexities.
The Hatch-Waxman Act permits a patent restoration term of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process.
The Hatch-Waxman Act permits a patent restoration term of up to five years for a patent covering an approved product as compensation for effective patent term lost as a result of product development and the FDA regulatory review process.
During the years ended December 31, 2024, 2023 and 2022, 3%, 6% and 10%, respectively, of our revenue was generated from customers located outside of the United States. We anticipate that international sales will continue to represent a portion of our total sales. In addition, some of our employees and suppliers are located outside of the United States.
During the years ended December 31, 2025, 2024 and 2023, 3%, 3% and 6%, respectively, of our revenue was generated from customers located outside of the United States. We anticipate that international sales will continue to represent a portion of our total sales. In addition, some of our employees and suppliers are located outside of the United States.
Depending upon the timing, duration and specifics of FDA marketing approval of our products, one or more of the U.S. patents we own or license may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
Depending upon the timing, duration and specifics of FDA marketing approval of our products, one or more of the U.S. patents we own or license may be eligible for patent term restoration (also referred to as patent term extension) under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Act.
As part of our services offered under our NOP, we have acquired a fleet of fixed-wing aircraft. All of the aircraft we currently operate are variants of a single model produced by a single manufacturer. Parts and services from this manufacturer are subject to their product and workmanship warranties and capacity to service aircraft.
As part of our services offered under our NOP, we have acquired a fleet of fixed-wing aircraft. All of the aircraft we currently operate are standardized variants of a certificated model produced by a single manufacturer. Parts and services from this manufacturer 36 are subject to their product and workmanship warranties and capacity to service aircraft.
Treasury and other federal agencies and authorities have a broad range of civil and criminal penalties they may seek to impose against corporations and individuals for violations of economic sanctions laws, export control laws, the FCPA and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC.
Treasury and other federal agencies and authorities, may seek to impose a broad range of civil and criminal penalties against corporations and individuals for violations of sanctions laws, export control laws, the FCPA, and other federal statutes and regulations, including those established by the Office of Foreign Assets Control, or OFAC.
We may not be able to achieve or maintain satisfactory pricing and margins for our products or services. Manufacturers of medical devices have a history of price competition, and we may not be able to achieve satisfactory prices for our products or maintain prices at the levels we have historically achieved.
Manufacturers of medical devices have a history of price competition, and we may not be able to achieve satisfactory prices for our products or maintain prices at the levels we have historically achieved.
Violations of the FCPA, OFAC restrictions, the Bribery Act or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could have a material adverse effect on our business, financial condition and results of operations.
Violations of the FCPA, OFAC restrictions, the Bribery Act or other export control, anti-corruption, anti-money laundering and anti-terrorism laws or regulations may result in severe criminal or civil sanctions, and other potential liabilities, which could have a material adverse effect on our business, financial condition, and results of operations.
As such, devices may continue to be placed on the EU market until the end of December 2027 or 2028 (depending on the class of device) and provided the manufacturer satisfies certain requirements, including that there are no significant changes in the design and intended purpose of these devices.
As such, devices CE marked under the Medical Devices Directive may continue to be placed on the EU market until the end of December 2027 or 2028 (depending on the class of device) and provided the manufacturer satisfies certain requirements, including that there are no significant changes in the design and intended purpose of these devices.
If we are unable to deliver OCS products to customers through their participation in the NOP, our revenue would be materially reduced, which would materially and adversely affect our business, financial condition, operating results, cash flows and prospects. We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS.
If we are unable to deliver OCS products to customers through their participation in the NOP, our revenue would be materially reduced, which would materially and adversely affect our business, financial condition, operating results, cash flows and prospects. 32 We depend on single-source suppliers and, in a few cases, sole-source suppliers for many of the components used in the OCS, and any supply interruption could harm our business.
If we do not comply with our obligations under the GDPR, we could be exposed to enforcement activity from EU regulators, including substantial fines and litigation. In addition, EU law restricts transfers of personal data to the United States unless certain requirements are met.
If we do not comply with our obligations under the GDPR, we could be exposed to enforcement activity from EU regulators, who may impose substantial fines, and civil litigation. In addition, EU law restricts transfers of personal data to the United States unless certain requirements are met.
In addition, in general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs, its research and development credit carryforwards and its disallowed interest expense carryovers to offset future taxable income.
In addition, a corporation that undergoes an “ownership change,” generally defined in Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as a greater than 50% change by value in its equity ownership over a three-year period, is subject to limitations on its ability to utilize its pre-change NOLs and its research and development credit carryforwards to offset future taxable income.
As of December 31, 2024, we had state NOL carryforwards of $349.6 million, which may be available to offset future taxable income and expire at various dates beginning in 2030.
As of December 31, 2025, we had state NOL carryforwards of $261.6 million, which may be available to offset future taxable income and expire at various dates beginning in 2030.
This activity may have an impact on the value of our common stock. We may not be able to sustain profitability. In recent years, we have incurred significant operating losses and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued customer utilization of our NOP.
This activity may have an impact on the value of our common stock. We may not be able to sustain profitability. Prior to 2024, we had incurred significant operating losses and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued customer utilization of our NOP.
In addition, the timing of acquiring additional aircraft for our aviation transportation services is uncertain and the amount we incur for such acquisitions is likely to differ from quarter to quarter. Our financial results in some quarters may fall below expectations.
In addition, we intend to opportunistically evaluate acquisitions of additional aircraft for our aviation transportation services, for which the timing is uncertain and the amount we incur for such acquisitions is likely to differ from quarter to quarter. Our financial results in some quarters may fall below expectations.
We may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under or refinance our indebtedness under the CIBC Credit Agreement, which is repayable in equal monthly installments starting in July 2026 until its maturity in July 2027.
We may not have sufficient funds, and may be unable to arrange for additional financing, to pay the amounts due under or refinance our indebtedness under the CIBC Credit Agreement, which is repayable in equal monthly installments starting in July 2026 and a final payment due at maturity in July 2027.
We might not be able to identify and qualify additional or replacement suppliers for any of these components quickly or at all or without incurring significant additional costs. We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all.
In such a case, we would be required to seek alternative suppliers. We might not be able to identify and qualify additional or replacement suppliers for any of these components quickly or at all or without incurring significant additional costs. We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at all.
Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements, and the QSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing our products, refusal to permit the import or export of our product, prohibition on sales of our product, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer. 52 We may not be able to obtain or maintain regulatory qualifications outside the United States, which could harm our business.
Our failure to comply with FDA or local requirements that pertain to clinical trials/investigations, including GCP requirements, and the QMSR (in the United States), or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, delays in approving or clearing our products, refusal to permit the import or export of our product, prohibition on sales of our product, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer.
The cost of the OCS significantly exceeds the cost of cold storage preservation. In addition, our international customers and some U.S. customers use a direct acquisition model pursuant to which transplant centers train their own teams for organ procurement and OCS perfusion management using the OCS rather than utilizing our NOP.
In addition, our international customers and some U.S. customers use a direct acquisition model pursuant to which transplant centers train their own teams for organ procurement and OCS perfusion management using the OCS rather than utilizing our NOP.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; • the federal Physician Sunshine Act under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred to as the Affordable Care Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and teaching hospitals.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; 54 • the federal Physician Payments Sunshine Act, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and other prescribers and teaching hospitals.
The FDA enforces the QSR through periodic inspections and unannounced “for cause” inspections. We are subject to periodic FDA inspections to determine compliance with QSR and pursuant to the Bioresearch Monitoring Program, which have in the past and may in the future result in the FDA issuing Form 483s, including during the conduct of clinical trials.
We are subject to periodic FDA inspections to determine compliance with the QSMR and pursuant to the Bioresearch Monitoring Program, which have in the past and may in the future result in the FDA issuing Form 483s, including during the conduct of clinical trials.
Litigation may be necessary to defend against claims, and it may be necessary or we may desire to enter into a license to settle any such claim; however, there can be no assurance that we would be able to obtain a license on commercially reasonable terms, if at all.
Litigation may be necessary to defend against claims, and it may be necessary or we may desire to enter into a license to settle any such claim; however, we may not be able to obtain a license on commercially reasonable terms, if at all.
We may not obtain international reimbursement approvals in a timely manner, if at all. In addition, even if we do obtain international reimbursement approvals, the level of reimbursement may not be enough to commercially justify expansion of our business into the approving jurisdiction.
In addition, even if we do obtain international reimbursement approvals, the level of reimbursement may not be enough to commercially justify expansion of our business into the 50 approving jurisdiction.
As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent.
As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, a court of competent jurisdiction may not invalidate the claims of any such U.S. patent.
However, even if, at the relevant time, we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to exercise due diligence during the testing phase or regulatory review process, to fail to apply within applicable deadlines or prior to expiration of relevant patents or otherwise to fail to satisfy applicable requirements.
However, even if, at the relevant time, we have an issued patent covering our product, we may not be granted an extension if we were, for example, to fail to apply within applicable deadlines or prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
Risks Related to Our Common Stock and General Risks The market price of our common stock has been and may continue to be volatile and could subject us to securities class action litigation. During the year ended December 31, 2024, the price per share of our common stock has ranged from as low as $58.27 to as high as $177.37.
Risks Related to Our Common Stock and General Risks The market price of our common stock has been and may continue to be volatile and could subject us to securities class action litigation. During the year ended December 31, 2025, the price per share of our common stock has ranged from as low as $55.00 to as high as $156.00.
Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims covering the approved product, a method for using it or a method for manufacturing it may be extended.
Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years after approval and only patents claiming the approved product, a method for using it or a method for manufacturing it may be extended.
We believe the NOP will continue to expand access and use of the OCS. However, continued operations of our NOP depend on recruiting, training and retaining qualified surgeons, clinical specialists, pilots, and other personnel and establishing and maintaining effective coordination with transplant centers and regional Organ Procurement Organizations to locate donor organs and recipients.
However, continued operations of our NOP depend on recruiting, training and retaining qualified surgeons, clinical specialists, pilots, and other personnel and establishing and maintaining effective coordination with transplant centers and regional Organ Procurement Organizations to locate donor organs and recipients.
If any third-party patents were asserted against us, even if we believe such claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability, or priority.
If any third-party patents were asserted against us, even if we believe such claims are without merit, a court may not find in our favor on questions of infringement, validity, enforceability, or priority.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
We may be unable to enforce our intellectual property rights throughout the world. The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
However, we cannot provide any assurances that any of our patents have, or that any of our pending patent applications that mature into issued patents will include, claims with a scope sufficient to protect our OCS technology, any additional features we develop for our OCS technology or any new products.
However, our patents or pending patent applications that mature into issued patents may not include claims with a scope sufficient to protect our OCS technology, any additional features we develop for our OCS technology or any new products.
The GDPR provides that EU member states may make their own further laws and regulations, including laws and regulations limiting the processing of genetic, biometric or health data, which could limit our ability to use and share personal data or cause our costs to increase, and harm our business and financial condition.
The GDPR also provides that EU member states may impose further conditions on the processing of personal data, including genetic, biometric and health data, which could limit our ability to use and share personal data or cause our costs to increase, and harm our business and financial condition.
From time to time, legislation is drafted and introduced in the U.S. Congress that could significantly change the statutory provisions governing the regulation of medical devices. In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.
Congress that could significantly change the statutory provisions governing the regulation of medical devices. In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business and our products.
We have implemented policies and procedures designed to ensure compliance by us and our directors, officers, employees, representatives, consultants and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations.
In addition, the Bribery 55 Act prohibits both domestic and international bribery across both private and public sectors. We have implemented policies and procedures designed to ensure compliance by us and our directors, officers, employees, representatives, consultants, and agents with the FCPA, OFAC restrictions, the Bribery Act and other export control, anti-corruption, anti-money-laundering and anti-terrorism laws and regulations.
We expect that we will need to continue to demonstrate to surgeons, transplant center program directors, Organ Procurement Organizations and private and public payors that the OCS potentially results in some or all of the following: improvements in post-transplant clinical outcomes, increases in the utilization of donor organs, expansion of the pool of potential donors and reduction in the total cost of care as compared to available alternatives. 31 Surgeons, transplant centers and private and public payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training.
We expect that we will need to continue to demonstrate to surgeons, transplant center program directors, Organ Procurement Organizations and private and public payors that the OCS potentially results in some or all of the following: improvements in post-transplant clinical outcomes, increases in the utilization of donor organs, expansion of the pool of potential donors and reduction in the total cost of care as compared to available alternatives.
For example, we are subject to the requirements of the GDPR, which imposes more stringent administrative requirements for controllers and processors of personal data, including, for example, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to health data and pseudonymized (i.e., key-coded) data, additional obligations when we contract with service providers, and more robust rights for individuals over their personal data.
For example, we are subject to the requirements of the GDPR, which imposes more stringent administrative requirements for controllers and processors of personal data, including, for example, demanding timelines for notifying personal data breaches, limitations on retention of personal information, stringent requirements pertaining to the processing of health data, rules regulating pseudonymized (i.e., key-coded) data, additional obligations when we contract with service provider processors, and robust rights for individuals with respect to their personal data.
Changes in accounting pronouncements or their interpretation or changes in underlying assumptions, estimates or judgments by our management could significantly change our reported or expected financial performance. 62 Item 1B. Unresolved Staff Comments. None.
Changes in accounting pronouncements or their interpretation or changes in underlying assumptions, estimates or judgments by our management could significantly change our reported or expected financial performance.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe believe that our current facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space would be readily available on commercially reasonable terms.
Biggest changeWe have additional distribution, commercial and research and development operations in Europe. We believe that these facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate alternative space would be readily available on commercially reasonable terms.
We have a designated maintenance hub for our aircraft in Dallas, Texas under a lease that expires in 2027, subject to certain early termination provisions. We also lease office space at various locations in the United States for our NOP and hangar space for our aircraft under short-term leases.
We have a designated maintenance hub for our aircraft in Dallas, Texas under a lease that expires in 2027, subject to certain early termination provisions. We also lease office space at various locations in the United States for our NOP and hangar space for our aircraft under both short-term and long-term leases.
Added
On January 8, 2026, we entered into a lease agreement with BioMed Realty for the lease of approximately 498,286 square feet of space located at 188 Assembly Park Drive, Somerville, Massachusetts for our principal executive offices and for research and development, laboratory, manufacturing and assembly, vivarium, office and related uses.
Added
The premises is expected to serve as our new headquarters and we expect to transition certain of our operations on or before January 1, 2028, ultimately replacing our existing headquarters in Andover, Massachusetts. Base rent begins to accrue in the first quarter of 2028.
Added
The lease will expire one hundred ninety-two (192) months from the date base rent begins to accrue, unless earlier terminated.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe complaint purports to assert claims against us and certain of our current and former officers pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder, on behalf of a putative class of investors who purchased or otherwise acquired the Company’s shares between February 28, 2023 and January 10, 2025 (the “class period”).
Biggest changeThe complaint purported to assert claims pursuant to Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 promulgated thereunder, seeking unspecified damages on behalf of a putative class of investors who purchased or otherwise acquired the Company’s shares between the Class Period, February 28, 2023 and January 10, 2025.
From time to time, we may be involved in other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. 63 Item 4. Mine Safety Disclosures. Not applicable. PART II
From time to time, we may be involved in other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. Item 4. Mine Safety Disclosures. Not applicable. PART II
Item 3. Legal Proceedings. On February 14, 2025, a class action captioned Merly Jewik v. TransMedics Group, Inc., et al., Case No. 1:25-cv-10385, was filed against us in the United States District Court for the District of Massachusetts.
Item 3. Legal Proceedings. On February 14, 2025, a class action captioned Jewik v. TransMedics Group, Inc., et al., Case No. 1:25-cv-10385, was filed against the Company and certain of its current and former officers in the U.S. District Court for the District of Massachusetts.
Removed
Plaintiff seeks to recover damages allegedly caused by purported misstatements and omissions contained in certain risk disclosures set forth in our 2022 and 2023 Annual Reports.
Added
On April 2, 2025, another purported stockholder filed a putative class action lawsuit against the Company and certain of its current and former officers, also in the U.S. District Court for the District of Massachusetts (Collins v. TransMedics Group, Inc., et al., Case No. 1:25-cv-10778).
Removed
The complaint alleges the disclosures at issue were false or misleading, because they failed to describe what plaintiff alleges were coercive business and marketing tactics, anticompetitive conduct and fraudulent billing activities on the part of the Company. The complaint claims these alleged statements and omissions operated to artificially inflate the price paid for our common stock during the class period.
Added
The Collins complaint alleged claims substantially similar to those alleged in the Jewik action and also sought unspecified damages.
Added
On May 22, 2025, the court consolidated the Jewik and Collins actions and appointed the Peace Officers’ Annuity and Benefit Fund of Georgia and Oguzhan Altun as lead plaintiffs, or the Lead Plaintiffs. 61 On August 8, 2025, Lead Plaintiffs filed a consolidated amended complaint.
Added
Like the earlier-filed complaints, the amended complaint purports to assert claims pursuant to Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5, on behalf of a putative class of investors who purchased or otherwise acquired the Company’s shares during the Class Period.
Added
Lead Plaintiffs seek unspecified damages allegedly caused by purported misstatements and omissions contained in our 2022 Annual Report, certain earnings calls, and other public statements. The amended complaint claims these alleged statements and omissions operated to artificially inflate the price paid for our common stock during the Class Period.
Added
On October 7, 2025, defendants filed a motion to dismiss the amended complaint for failure to state a claim. Lead Plaintiffs’ filed their response to the motion on November 21, 2025, and defendants’ filed a reply in further support of their motion on December 22, 2025. We cannot anticipate when the court will rule on that motion.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeCOMPARISON OF 60 MONTH CUMULATIVE TOTAL RETURN Among TransMedics Group, Inc., the NASDAQ Composite Index and the NASDAQ Healthcare Index 64 (1) This performance graph shall not be deemed to be "soliciting material" or to be "filed" with the SEC for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section, and shall not be deemed incorporated by reference into any filings of TransMedics Group, Inc. under the Securities Act of 1933, as amended.
Biggest changeData for the NASDAQ Composite Index and the NASDAQ Healthcare Index assumed reinvestment of dividends. 62 COMPARISON OF 60 MONTH CUMULATIVE TOTAL RETURN Among TransMedics Group, Inc., the NASDAQ Composite Index and the NASDAQ Healthcare Index (1) This performance graph shall not be deemed to be "soliciting material" or to be "filed" with the SEC for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section, and shall not be deemed incorporated by reference into any filings of TransMedics Group, Inc. under the Securities Act of 1933, as amended.
Any future determination to declare and pay cash dividends, if any, will be made at the discretion of our board of directors and will depend on a variety of factors, including applicable laws, our financial condition, results of operations, contractual restrictions, capital requirements, business prospects, general business or financial market conditions and other factors our board of directors may deem relevant.
Any future determination to declare and pay cash dividends, if any, will be made at the discretion of our board of directors and will depend on a variety of factors, including applicable laws, our financial condition, results of operations, contractual restrictions, capital requirements, business prospects, general business or financial market 63 conditions and other factors our board of directors may deem relevant.
Securities authorized for issuance under equity compensation plans Information about our equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2025 Annual Meeting of Stockholders and is incorporated herein by reference. Recent Sales of Unregistered Equity Securities None.
Securities authorized for issuance under equity compensation plans Information about our equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference. Recent Sales of Unregistered Equity Securities None.
Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period from September 30, 2024 to December 31, 2024. Dividends We have never declared or paid any dividends on our capital stock. We do not anticipate declaring or paying any cash dividends on our capital stock in the foreseeable future.
Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period from September 30, 2025 to December 31, 2025. Dividends We have never declared or paid any dividends on our capital stock. We do not anticipate declaring or paying any cash dividends on our capital stock in the foreseeable future.
Stock Performance Graph (1) The following graph shows a comparison from December 31, 2019 through December 31, 2024 of cumulative total return on assumed investments of $100.00 in cash in each of our common stock, the NASDAQ Composite Index and the NASDAQ Healthcare Index. Such returns are based on historical results and are not intended to suggest future performance.
Stock Performance Graph (1) The following graph shows a comparison from December 31, 2020 through December 31, 2025 of cumulative total return on assumed investments of $100.00 in cash in each of our common stock, the NASDAQ Composite Index and the NASDAQ Healthcare Index. Such returns are based on historical results and are not intended to suggest future performance.
In addition, our CIBC Credit Agreement contains covenants that restrict our ability to pay cash dividends. Item 6. Reserved 65
In addition, our CIBC Credit Agreement contains covenants that restrict our ability to pay cash dividends. Item 6. Reserved 64
Holders of Our Common Stock As of January 31, 2025, there were approximately 20 holders of record of shares of our common stock. These amounts do not include stockholders for whom shares are held in “nominee” or “street” name.
Holders of Our Common Stock As of January 30, 2026, there were approximately 20 holders of record of shares of our common stock. These amounts do not include stockholders for whom shares are held in “nominee” or “street” name.
Removed
Data for the NASDAQ Composite Index and the NASDAQ Healthcare Index assumed reinvestment of dividends.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeOperating Expenses Research, Development and Clinical Trials Expenses Research, development and clinical trials expenses consist primarily of costs incurred for our research activities, product development, hardware and software engineering, clinical trials to continue to develop clinical evidence of our products’ safety and effectiveness, regulatory expenses, testing, consultant services and other costs associated with our OCS technology platform and OCS products, which include: • employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research, hardware and software development, regulatory and clinical trial functions, and recruiting and temporary service fees related to such personnel; • expenses incurred in connection with the clinical trials of our products, including under agreements with third parties, such as consultants, contractors and data management organizations; • the cost of maintaining and improving our product designs, including the testing of materials and parts used in our products; • laboratory supplies and research materials; and • facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities and insurance. 68 We expense research, development and clinical trials costs as incurred.
Biggest changeOperating Expenses Research, Development and Clinical Trials Expenses Research, development and clinical trials expenses consist of costs incurred for research activities, product development, hardware and software engineering and clinical trial activities, including salaries and related costs, including stock-based compensation, facilities costs, laboratory supplies, depreciation, testing, regulatory, data management and consulting costs.
Financing Activities During the year ended December 31, 2024, net cash provided by financing activities of $22.9 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $20.8 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $2.1 million.
During the year ended December 31, 2024, net cash provided by financing activities of $22.9 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $20.8 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $2.1 million.
For each new transplant procedure, these customers purchase an additional OCS disposable set for use on their existing organ-specific OCS Console. We also generate service revenue by providing outsourced organ procurement, OCS perfusion management and transplant logistics services under our NOP in the United States.
For each new transplant procedure, these customers purchase an additional OCS disposable set for use on their existing organ-specific OCS Console. We also generate service revenue by providing outsourced organ procurement, OCS perfusion management and transplant logistics services under our NOP in the United States.
We recognize revenue from the single, combined performance obligation only once the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by us. 77 Customer orders may include the loan of an OCS Console as well as OCS disposable sets used in each transplant procedure.
We recognize revenue from the single, combined performance obligation only once the OCS Console has arrived at the customer site and the training and equipment set-up have been completed by us. Customer orders may include the loan of an OCS Console as well as OCS disposable sets used in each transplant procedure.
Components of Our Results of Operations Revenue We generate net product revenue primarily from sales of our single-use, organ-specific disposable sets used on our organ-specific OCS Consoles. To a lesser extent, we also generate product revenue from the sale of OCS Consoles to customers and the implied rental of OCS Consoles loaned to customers at no charge.
Key Components of Our Results of Operations Revenue We generate net product revenue primarily from sales of our single-use, organ-specific disposable sets used on our organ-specific OCS Consoles. To a lesser extent, we also generate product revenue from the sale of OCS Consoles to customers and the implied rental of OCS Consoles loaned to customers at no charge.
Cost of service revenue primarily consists of labor and overhead that directly support organ procurement and OCS perfusion management services and transportation and logistics costs, including labor costs for pilots, aircraft depreciation, aircraft costs, fuel, crew travel, maintenance and third-party flight costs and ground transportation that support organ delivery.
Cost of service revenue primarily consists of labor and overhead that directly support organ procurement and OCS perfusion management services and transportation and transplant logistics costs, including labor costs for pilots, aircraft depreciation, aircraft costs, fuel, crew travel, maintenance and third-party flight costs and ground transportation that support organ delivery.
Economic Impacts Inflation, changes in trade policies, and the imposition of duties and tariffs have and could continue to adversely impact the price or availability of raw materials, the components of our products as well as shipping and transportation costs.
Economic Impacts Inflation, changes in trade policies, and the imposition of or changes in the amount of duties and tariffs have and could continue to adversely impact the price or availability of raw materials, the components of our products as well as shipping and transportation costs.
We expect that our selling, general and administrative expenses will increase over the long term as we increase our headcount to support the expected continued sales growth of our OCS products and our NOP.
We expect that our selling, general and administrative expenses will increase over the long term as we increase our headcount and infrastructure to support the expected continued sales growth of our OCS products and our NOP.
For example, if the demand for our products exceeds our existing manufacturing and sterilization capacity, our ability to fulfill orders would be limited until we have sufficiently expanded such operations.
If the demand for our products exceeds our existing manufacturing and sterilization capacity, our ability to fulfill orders would be limited until we have sufficiently expanded such operations.
In addition, we received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung. 67 We expect that our revenue will increase over the long term as a result of the continued growth of the NOP in the United States.
In addition, we received a Class II Medical Device License from Health Canada for our OCS Liver combined with our solution additives in October 2023 to complement our existing Health Canada licenses for OCS Heart and OCS Lung. 66 We expect that our revenue will increase over the long term as a result of the continued growth of the NOP in the United States.
Liquidity and Capital Resources Prior to 2024, we had incurred significant annual operating losses since inception and we may continue to incur losses in the future.
Liquidity and Capital Resources Prior to 2024, we had incurred significant annual operating losses since inception and we may incur losses in the future.
Other Income (Expense) Interest Expense Interest expense consists of interest expense associated with outstanding borrowings under our loan agreements as well as the amortization of debt discounts associated with such agreements. In July 2022, we entered into a credit agreement with Canadian Imperial Bank of Commerce, or CIBC, under which we borrowed $60.0 million.
Other Income (Expense) Interest Expense Interest expense consists of interest expense associated with outstanding borrowings under our loan agreement and our Notes as well as the amortization of debt discounts associated with such agreements. In July 2022, we entered into a credit agreement with Canadian Imperial Bank of Commerce, or CIBC, under which we borrowed $60.0 million.
As of December 31, 2024, we were in compliance with all financial covenants of the CIBC Credit Agreement. During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0%.
As of December 31, 2025, we were in compliance with all financial covenants of the CIBC Credit Agreement. During the continuance of an event of default, the interest rate per annum will be equal to the rate that would have otherwise been applicable at the time of the event of default plus 2.0%.
While we expect our revenue to increase over the long term, revenue from sales may fluctuate from quarter to quarter as the timing of organ transplant procedures is generally unpredictable, and we have observed periodic fluctuations in the availability of donor organs, which impacts the volume of transplants.
While we expect our revenue to increase over the long term, revenue from sales may fluctuate from quarter to quarter as the timing of organ transplant procedures is generally unpredictable, and we have observed periodic fluctuations in the availability of donor organs and transplant center surgeons, which impacts the volume of transplants.
Prior to 2024, we had incurred significant annual operating losses since inception and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued commercial sales of our OCS products and NOP services.
Prior to 2024, we had incurred significant annual operating losses since inception and we have only recently achieved profitability. Our ability to generate revenue sufficient to achieve sustained profitability will depend on the continued commercial sales of our products and services.
For a discussion of our cash flows for the year ended December 31, 2022, see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Cash Flows included in our Annual Report on Form 10-K for the year ended December 31, 2023.
For a discussion of our cash flows for the year ended December 31, 2023, see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Cash Flows included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Components of Our Results of Operations—Comparison of the Years Ended December 31, 2023, 2022 and 2021 included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Management’s Discussion and Analysis of Financial Condition and Results of Operations—Components of Our Results of Operations—Comparison of the Years Ended December 31, 2024, 2023 and 2022 included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Through December 31, 2024, all of our sales outside of the United States have been commercial sales (unrelated to any clinical trials). Our sales in the EU are dependent on obtaining and maintaining the CE mark certifications for each of our OCS products.
Through December 31, 2025, our sales outside of the United States have been commercial sales (unrelated to any clinical trials). Sales in the EU are dependent on obtaining and maintaining the CE mark certifications for each of our OCS products.
The timing and amount of our operating and capital expenditures will depend on many factors, including: • the amount of product revenue generated by sales of our OCS Consoles, OCS disposable sets and other products that may be approved in the United States and select non-U.S. markets, revenue generated by our services, and growth of the NOP; • the costs and expenses of expanding our U.S. and non-U.S. sales and marketing infrastructure and our manufacturing operations; • the extent to which our OCS products are adopted by the transplant community; • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products; • the degree of success we experience in commercializing our OCS products for additional indications; • the costs, timing and outcomes of post-approval studies or any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products; • the emergence of competing or complementary technologies or procedures; • the number and types of future products we develop and commercialize; • the cost of development of the next generation OCS; • the costs associated with maintaining and improving our commercial operations, including the NOP; • the costs associated with maintaining and growing our logistics capabilities, including by means of attracting, training and retaining pilots, and the acquisition, maintenance, or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments; • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and • the level of our selling, general and administrative expenses.
The timing and amount of our operating and capital expenditures will depend on many factors, including: • the amount of product revenue generated by sales of our OCS Consoles, OCS disposable sets and other products that may be approved in the United States and select non-U.S. markets, revenue generated by our services, and growth of the NOP; • the costs and expenses of expanding our U.S. and non-U.S. sales, marketing and logistics infrastructure and our manufacturing operations; • the extent to which our OCS products are adopted by the transplant community; • the ability of our customers to obtain adequate reimbursement from third-party payors for procedures performed using the OCS products; • the degree of success we experience in commercializing our OCS products for additional indications; • the costs, timing and outcomes of pre- and post-approval studies or any future clinical studies and regulatory reviews, including to seek and obtain approvals for new indications for our OCS products; 74 • the emergence of competing or complementary technologies or procedures; • the number and types of future products we develop and commercialize; • the cost of constructing research and development and manufacturing facilities in Italy; • the cost and timing of development of the next generation OCS; • the costs associated with maintaining, improving and expanding our commercial operations, including the NOP globally; • the costs associated with maintaining and growing our transplant logistics capabilities, including by means of attracting, training and retaining pilots, and the acquisition, maintenance, or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments; • the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; • the level of our selling, general and administrative expenses; and • the costs related to establishing and relocating to a new long-term global headquarters to accommodate the growing scale and complexity of our business.
Any write-down of inventory to net realizable value creates a new cost basis. The reserve for excess and obsolete inventory was $2.5 million and $0.8 million as of December 31, 2024 and 2023, respectively.
Any write-down of inventory to net realizable value creates a new cost basis. The reserve for excess and obsolete inventory was $3.0 million and $2.5 million as of December 31, 2025 and 2024, respectively.
Laboratory supplies and research materials costs increased by $6.1 million from the year ended December 31, 2023 to the year ended December 31, 2024 primarily due to our increased need for supplies and materials used for development of our next generation OCS.
Laboratory supplies and research materials costs increased by $3.6 million from the year ended December 31, 2024 to the year ended December 31, 2025 primarily due to our increased need for supplies and materials used for development of our next generation OCS.
We lease facilities under long-term non-cancelable operating leases that have a weighted average remaining lease term of 3.7 years as of December 31, 2024. As of December 31, 2024, we had fixed lease payment obligations of $10.3 million, of which $3.3 million is payable during 2025.
We lease facilities under long-term non-cancelable operating leases that have a weighted average remaining lease term of 2.8 years as of December 31, 2025. As of December 31, 2025, we had fixed lease payment obligations of $7.8 million, of which $3.7 million is payable during 2026.
If we are unable to raise capital or enter into such agreements as, and when, needed, we will have to delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to terminate our operations. 66 In March 2023, the U.S.
If we are unable to raise capital or enter into such agreements as, and when, needed, we will have to delay, scale back or discontinue the further development and commercialization efforts of one or more of our products, or may be forced to terminate our operations.
Personnel related costs increased by $6.4 million primarily due to increased headcount to support development efforts for our next generation OCS and overall compensation increases. Personnel related costs included stock-based compensation expense of $4.2 million and $2.8 million for the years ended December 31, 2024 and 2023, respectively.
Personnel related costs increased by $3.8 million primarily due to increased headcount to support development efforts for our next generation OCS program and overall compensation increases. Personnel related costs included stock-based compensation expense of $4.7 million and $4.2 million for the years ended December 31, 2025 and 2024, respectively.
In January 2021, we entered into an unconditional $9.5 million purchase commitment in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029. The contract is not cancellable without penalty. As of December 31, 2024, our remaining purchase commitment is $5.0 million.
In January 2021, we entered into an unconditional $9.5 million purchase commitment in the ordinary course of business, for goods with specified annual minimum quantities to be purchased through December 2029. The contract is not cancellable without penalty.
In the future, we expect that research, development and clinical trials expenses will increase over the long term due to ongoing product development and approval efforts.
We expense research, development and clinical trials costs as incurred. In the future, we expect that research, development and clinical trials expenses will increase over the long term due to ongoing product development and approval efforts.
Our estimate of payments is based on an assumed rate of 6.4%, which was the interest rate in effect at December 31, 2024. On May 11, 2023, we issued $460.0 million aggregate principal amount of the Notes.
Our estimate of interest payments is based on an assumed rate of 5.7%, which was the interest rate in effect at December 31, 2025. On May 11, 2023, we issued $460.0 million aggregate principal amount of the Notes.
We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS.
We have also developed our NOP, an innovative turnkey solution to provide outsourced organ procurement, OCS perfusion management and transplant logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. Our transplant logistics services include aviation transportation, ground transportation, and other coordination activity.
Cost of service revenue included approximately $3.1 million and $4.4 million for the years ended December 31, 2024 and 2023, respectively, of costs from Summit's legacy operations, unrelated to the NOP and organ transplant. Overall gross margin was 59% and 64% for the years ended December 31, 2024 and 2023, respectively.
Cost of service revenue included approximately $2.9 million and $3.1 million for the years ended December 31, 2025 and 2024, respectively, of costs from Summit's legacy operations, unrelated to the NOP and organ transplant. Overall gross margin was 60% and 59% for the years ended December 31, 2025 and 2024, respectively.
Revenue from customers outside the United States was $15.3 million and $15.4 million in the years ended December 31, 2024 and 2023, respectively. Cost of Revenue, Gross Profit and Gross Margin Cost of net product revenue increased by $17.3 million in the year ended December 31, 2024 compared to the year ended December 31, 2023.
Revenue from customers outside the United States was $16.7 million and $15.3 million in the years ended December 31, 2025 and 2024, respectively. Cost of Revenue, Gross Profit and Gross Margin Cost of net product revenue increased by $19.5 million in the year ended December 31, 2025 compared to the year ended December 31, 2024.
We also enter into other contracts in the normal course of business with consulting firms, material suppliers and other third parties for clinical trials and testing and manufacturing services. These contracts do not contain material minimum purchase commitments and are cancelable by us upon prior written notice.
As of December 31, 2025, our remaining purchase commitment is $4.0 million. 75 We also enter into other contracts in the normal course of business with consulting firms, material suppliers and other third parties for clinical trials and testing and manufacturing services. These contracts do not contain material minimum purchase commitments and are cancelable by us upon prior written notice.
Revenue from sales to customers of OCS Perfusion Sets, OCS Solutions and OCS Consoles is classified as net product revenue in the our consolidated statements of operations. Revenue from sales to customers of organ procurement, OCS perfusion management and transplant logistics services is classified as service revenue in our consolidated statements of operations.
Revenue from sales to customers of OCS Perfusion Sets, OCS Solutions and OCS Consoles is classified as net product revenue in the our consolidated statements of operations.
A conditional conversion feature of the Notes was triggered on June 30, 2024 and again on September 30, 2024, as the last reported sale price of our common stock was greater than or equal to 130% of the conversion price of the Notes for at least 20 trading days during the period of 30 consecutive trading days ending on and including the last trading day of each of the quarters ended June 30, 2024 and September 30, 2024, respectively, and the Notes therefore became convertible at the noteholders’ election in the immediately following calendar quarters ended September 30, 2024 and December 31, 2024, respectively.
A conditional conversion feature of the Notes was triggered on December 31, 2025, as the last reported sale price of our common stock was greater than or equal to 130% of the conversion price of the Notes for at least 20 trading days during the period of 30 consecutive trading days ending on and including the last trading day of the quarter ended December 31, 2025, and the Notes therefore became convertible at the noteholders’ election in the calendar quarter ending March 31, 2026 (and only during this calendar quarter).
With the acquisition of Summit in August 2023, the purchase of fixed-wing transplant aircraft and the addition of a logistics team, we anticipate increased service revenue from our logistics services. Prior to our acquisition in 2023, Summit derived its revenue primarily from charter flight services.
With the acquisition of Summit in August 2023, the purchase of fixed-wing transplant aircraft and the addition of a logistics team, we have increased service revenue from our transplant logistics services.
Organ Procurement and Transplantation Network Act was signed into law and expressly authorizes HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTN and specifies that the OPTN shall be operated through awards that are distinct from awards made to support the organization tasked with supporting the networks’ board of directors.
Organ Procurement and Transplantation Network Act was signed into law. This legislation expressly authorizes HRSA to award multiple grants, contracts or cooperative agreements to support the operation of the OPTN. It also specifies that the awards to operate the OPTN shall be distinct from awards to support the networks’ board of directors.
At our option, we may prepay borrowings outstanding under the CIBC Credit Agreement, without a prepayment fee. All obligations under the CIBC Credit Agreement are guaranteed by us and each of our material subsidiaries. All obligations of us and each guarantor are secured by substantially all of our and each guarantor’s assets, including their intellectual property, subject to certain exceptions.
All obligations under the CIBC Credit Agreement are guaranteed by us and each of our material subsidiaries. All obligations of us and each guarantor are secured by substantially all of our and each guarantor’s assets, including their intellectual property, subject to certain exceptions.
As of December 31, 2024, our outstanding principal balance was $60.0 million, which is repayable in equal monthly installments starting in July 2026 until its maturity in July 2027. We estimate we will pay $3.9 million in interest payments during 2025.
As of December 31, 2025, our outstanding principal balance was $60.0 million, which is repayable in equal monthly installments starting in July 2026 with the remaining balance due on the maturity date in July 2027. We estimate we will pay $10.0 million in principal payments and $3.4 million in interest payments during 2026.
At December 31, 2024, our principal source of liquidity was cash of $336.7 million Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Year Ended December 31, 2024 2023 2022 (in thousands) Net cash provided by (used in) operating activities $ 48,803 $ (13,028 ) $ (45,817 ) Net cash provided by (used in) investing activities (129,303 ) (193,953 ) 54,513 Net cash provided by financing activities 22,874 400,418 167,927 Effect of exchange rate changes on cash, cash equivalents and restricted cash (536 ) 193 (1,021 ) Net increase (decrease) in cash, cash equivalents and restricted cash $ (58,162 ) $ 193,630 $ 175,602 Operating Activities During the year ended December 31, 2024, operating activities provided $48.8 million of cash, primarily resulting from our net income of $35.5 million and net non-cash charges of $58.3 million, partially offset by net cash used by changes in our operating assets and liabilities of $45.0 million.
At December 31, 2025, our principal source of liquidity was cash of $488.4 million Cash Flows The following table summarizes our sources and uses of cash for each of the periods presented: Year Ended December 31, 2025 2024 2023 (in thousands) Net cash provided by (used in) operating activities $ 192,840 $ 48,803 $ (13,028 ) Net cash used in investing activities (59,251 ) (129,303 ) (193,953 ) Net cash provided by financing activities 16,857 22,874 400,418 Effect of exchange rate changes on cash and restricted cash 1,270 (536 ) 193 Net increase (decrease) in cash and restricted cash $ 151,716 $ (58,162 ) $ 193,630 Operating Activities During the year ended December 31, 2025, operating activities provided $192.8 million of cash, primarily resulting from our net income of $190.3 million and net cash provided by changes in our operating assets and liabilities of $18.4 million, partially offset by net non-cash income of $15.8 million.
Cost of service revenue increased by $74.6 million in the year ended December 31, 2024 compared to the year ended December 31, 2023 as we increased utilization of the NOP. Gross profit increased by $108.0 million in the year ended December 31, 2024 compared to the year ended December 31, 2023.
Cost of service revenue increased by $43.8 million in the year ended December 31, 2025 compared to the year ended December 31, 2024 as we increased utilization of the NOP. Gross profit increased by $100.7 million in the year ended December 31, 2025 compared to the year ended December 31, 2024.
In September 2024, HRSA began awarding contracts aimed at supporting these initiatives. The impact that the HRSA initiatives and the U.S. Organ Procurement and Transplantation Network Act may have on our business, including on our NOP, is uncertain at this time.
The impact that HRSA's initiatives and the U.S. Organ Procurement and Transplantation Network Act may have on our business, including on our NOP, is uncertain at this time.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
Adjustments to fair values of assets and liabilities made after the end of the measurement period are recorded within operating results. 77 Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
The increase in product gross margin was primarily as a result of increased sales volume and increased sales of higher margin OCS disposable sets. Gross margin from service revenue was 28% and 29% for the years ended December 31, 2024 and 2023, respectively, and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP.
Gross margin from net product revenue was 79% for each of the years ended December 31, 2025 and 2024. Gross margin from service revenue was 29% and 28% for the years ended December 31, 2025 and 2024, respectively, and consisted primarily of organ procurement, OCS perfusion management and transplant logistics services under our NOP.
For example, the global economy has experienced extreme volatility and disruptions, including significant volatility in commodity, other material and labor costs, declines in consumer confidence, declines in economic growth, supply chain interruptions, uncertainty about economic stability and record inflation globally.
For example, tariffs related to a small portion of components that we import moderately increased our cost of revenue in 2025. The global economy has experienced extreme volatility and disruptions, including significant volatility in commodity, other material and labor costs, declines in consumer confidence, declines in economic growth, supply chain interruptions, uncertainty about economic stability and record inflation globally.
Investing Activities During the year ended December 31, 2024, net cash used in investing activities of $129.3 million consisted primarily of purchases of property, plant and equipment of $129.7 million, including an increase of $110.2 million in transplant aircraft.
Investing Activities During the year ended December 31, 2025, net cash used in investing activities of $59.3 million consisted of purchases of property, plant and equipment, primarily related to the purchase of transplant aircraft.
As of the end of each reporting period presented in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we did not identify any potential losses arising from remaining future purchase commitments as compared to estimated future customer sales through the remainder of the term of the manufacturing purchase commitment and, as a result, did not recognize in a current period any loss provision for future-period remaining purchase commitments. 78 Business Combinations and Fair Value Estimates In determining whether an acquisition should be accounted for as a business combination or asset acquisition, we first determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets.
As of the end of each reporting period presented in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we did not identify any potential losses arising from remaining future purchase commitments as compared to estimated future customer sales through the remainder of the term of the manufacturing purchase commitment and, as a result, did not recognize in a current period any loss provision for future-period remaining purchase commitments.
We generated total revenue of $441.5 million and had net income of $35.5 million for the year ended December 31, 2024. We generated total revenue of $241.6 million and incurred a net loss of $25.0 million for the year ended December 31, 2023. As of December 31, 2024, we had an accumulated deficit of $468.2 million.
We generated total revenue of $605.5 million and had net income of $190.3 million for the year ended December 31, 2025. We generated total revenue of $441.5 million and had net income of $35.5 million for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $278.0 million.
In addition, we may be required to prepay outstanding borrowings, subject to certain exceptions, with portions of net cash proceeds of certain asset sales and certain casualty and condemnation events. 75 Funding Requirements As we continue to pursue and increase commercial sales of our OCS products, we expect our costs and expenses to increase in the future, particularly as we expand our commercial team, grow our NOP, scale our manufacturing and sterilization operations, continue research, development and clinical trial efforts, seek regulatory approval for new products and product enhancements, including new indications, both in the United States and in select non-U.S. markets, and seek greater control of air and ground transport for our NOP.
Funding Requirements As we continue to pursue and increase commercial sales of our OCS products, we expect our costs and expenses to increase in the future, particularly as we expand our commercial team, grow our NOP, scale our manufacturing and sterilization operations, continue research, development and clinical trial efforts, including expanding our research and development and manufacturing capabilities in Italy, seek regulatory approval for the next generation OCS, new products and product enhancements, including new indications, both in the United States and in select non-U.S. markets, establish and relocate to a new long-term global headquarters, and seek greater control of air and ground transport for our NOP.
Department of Health and Human Services’ Health Resources and Services Administration, or HRSA, announced initiatives designed to improve the OPTN, including its intent to solicit contract proposals to manage the OPTN, which is currently operated by the United Network for Organ Sharing, or UNOS, under a contract that expired in March 2024. Additionally, in September 2023, the Securing the U.S.
Department of Health and Human Services’ Health Resources and Services Administration, or HRSA, announced initiatives designed to improve the OPTN, including its intent to solicit contract proposals to manage the OPTN under a multi-vendor model following the expiration of the sole-vendor contract between UNOS and HRSA on March 29, 2024. Additionally, in September 2023, the Securing the U.S.
From and after March 1, 2028, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date.
From and after March 1, 2028, noteholders may convert their Notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. We have the right to elect to settle conversions either in cash, shares or in a combination of cash and shares of our common stock.
Foreign currency transaction gains and losses result from intercompany transactions as well as transactions with customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded. 69 Results of Operations Comparison of the Years Ended December 31, 2024, 2023 and 2022 The following table summarizes our results of operations for the years ended December 31, 2024, 2023 and 2022: Year Ended December 31, 2024 2023 2022 (in thousands) Revenue: Net product revenue $ 273,866 $ 176,069 $ 79,234 Service revenue 167,674 65,554 14,225 Total revenue 441,540 241,623 93,459 Cost of revenue: Cost of net product revenue 58,345 41,015 16,970 Cost of service revenue 121,114 46,515 11,217 Total cost of revenue 179,459 87,530 28,187 Gross profit 262,081 154,093 65,272 Operating expenses: Research, development and clinical trials 55,968 36,055 26,812 Acquired in-process research and development expenses — 27,212 — Selling, general and administrative 168,617 119,553 69,897 Total operating expenses 224,585 182,820 96,709 Income (loss) from operations 37,496 (28,727 ) (31,437 ) Other income (expense): Interest expense (14,409 ) (10,791 ) (3,726 ) Interest income and other income (expense), net 12,693 12,847 (1,002 ) Total other income (expense), net (1,716 ) 2,056 (4,728 ) Income (loss) before income taxes 35,780 (26,671 ) (36,165 ) (Provision) benefit for income taxes (316 ) 1,643 (66 ) Net income (loss) $ 35,464 $ (25,028 ) $ (36,231 ) Revenue OCS transplant-related revenue consists of: Year Ended December 31, 2024 2023 Change (in thousands) OCS transplant revenue by country by organ: United States Lung total revenue $ 15,755 $ 10,548 $ 5,207 Heart total revenue 96,663 59,080 37,583 Liver total revenue 309,462 151,719 157,743 Total United States OCS transplant revenue 421,880 221,347 200,533 All other countries Lung total revenue 1,926 1,272 654 Heart total revenue 13,198 14,012 (814 ) Liver total revenue 158 104 54 Total all other countries OCS transplant revenue 15,282 15,388 (106 ) Total OCS transplant revenue $ 437,162 $ 236,735 $ 200,427 We also had service revenue unrelated to OCS transplant of $4.4 million and $4.9 million for the years ended December 31, 2024 and 2023, respectively. 70 Revenue from customers in the United States related to OCS transplant was $421.9 million in the year ended December 31, 2024 and increased by $200.5 million compared to the year ended December 31, 2023, primarily due to higher sales volumes of our OCS Liver and OCS Heart disposable sets.
To the extent allowed, we intend to use our available net operating loss carryforwards and tax credits to reduce cash tax payment obligations. 68 Results of Operations Comparison of the Years Ended December 31, 2025, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2025, 2024 and 2023: Year Ended December 31, 2025 2024 2023 (in thousands) Revenue: Net product revenue $ 372,401 $ 273,866 $ 176,069 Service revenue 233,093 167,674 65,554 Total revenue 605,494 441,540 241,623 Cost of revenue: Cost of net product revenue 77,822 58,345 41,015 Cost of service revenue 164,866 121,114 46,515 Total cost of revenue 242,688 179,459 87,530 Gross profit 362,806 262,081 154,093 Operating expenses: Research, development and clinical trials 69,055 55,968 36,055 Acquired in-process research and development expenses — — 27,212 Selling, general and administrative 185,168 168,617 119,553 Total operating expenses 254,223 224,585 182,820 Income (loss) from operations 108,583 37,496 (28,727 ) Other income (expense): Interest expense (13,782 ) (14,409 ) (10,791 ) Interest income and other income (expense), net 12,721 12,693 12,847 Total other income (expense), net (1,061 ) (1,716 ) 2,056 Income (loss) before income taxes 107,522 35,780 (26,671 ) (Provision) benefit for income taxes 82,769 (316 ) 1,643 Net income (loss) $ 190,291 $ 35,464 $ (25,028 ) Revenue OCS transplant-related revenue consists of: Year Ended December 31, 2025 2024 2023 (in thousands) OCS transplant revenue by country by organ: United States Lung total revenue $ 13,443 $ 15,755 $ 10,548 Heart total revenue 111,839 96,663 59,080 Liver total revenue 459,415 309,462 151,719 Total United States OCS transplant revenue 584,697 421,880 221,347 All other countries Lung total revenue 1,418 1,926 1,272 Heart total revenue 14,169 13,198 14,012 Liver total revenue 1,113 158 104 Total all other countries OCS transplant revenue 16,700 15,282 15,388 Total OCS transplant revenue $ 601,397 $ 437,162 $ 236,735 We also had service revenue unrelated to OCS transplant of $4.1 million, $4.4 million and $4.9 million for the years ended December 31, 2025, 2024 and 2023, respectively. 69 Revenue from customers in the United States related to OCS transplant was $584.7 million in the year ended December 31, 2025 and increased by $162.8 million compared to the year ended December 31, 2024, primarily due to higher sales volumes of our OCS Liver and OCS Heart disposable sets.
Interest Income and Other Income (Expense), Net Interest income and other income (expense), net for the years ended December 31, 2024 and 2023 included interest income of $13.4 million and $12.5 million, respectively, from interest earned on invested cash balances.
Interest Income and Other Income (Expense), Net Interest income and other income (expense), net for the years ended December 31, 2025 and 2024 included interest income of $11.4 million and $13.4 million, respectively, from interest earned on cash balances. The decrease in interest income was primarily due to lower yields on our cash balances.
Operating Expenses Research, Development and Clinical Trials Expenses Year Ended December 31, 2024 2023 Change (in thousands) Personnel related (including stock-based compensation expense) $ 21,927 $ 15,489 $ 6,438 Laboratory supplies and research materials 13,990 7,939 6,051 Consulting and third-party services 12,920 5,788 7,132 Clinical trials costs 478 1,077 (599 ) Facility related and other 6,653 5,762 891 Total research, development and clinical trials expenses $ 55,968 $ 36,055 $ 19,913 71 Total research, development and clinical trials expenses increased by $19.9 million from $36.1 million in the year ended December 31, 2023 to $56.0 million in the year ended December 31, 2024.
Operating Expenses Research, Development and Clinical Trials Expenses Year Ended December 31, 2025 2024 Change (in thousands) Personnel related (including stock-based compensation expense) $ 25,720 $ 21,927 $ 3,793 Laboratory supplies and research materials 17,550 13,990 3,560 Consulting and third-party services 15,492 12,920 2,572 Clinical trials costs 1,459 478 981 Facility related and other 8,834 6,653 2,181 Total research, development and clinical trials expenses $ 69,055 $ 55,968 $ 13,087 Total research, development and clinical trials expenses increased by $13.1 million from $56.0 million in the year ended December 31, 2024 to $69.1 million in the year ended December 31, 2025.
Other income (expense), net included $0.7 million of realized and unrealized foreign currency transactions losses for the year ended December 31, 2024, and $0.3 million of realized and unrealized foreign currency transactions gains during the year ended December 31, 2023. 72 (Provision) Benefit for Income Taxes Income taxes for the years ended December 31, 2024 and 2023 included a tax provision of $0.3 million and less than $0.1 million, respectively, related to state and foreign income taxes.
Interest income and other income (expense), net also included $1.0 million of realized and unrealized foreign currency transactions gains for the year ended December 31, 2025, and $0.7 million of realized and unrealized foreign currency transactions losses during the year ended December 31, 2024.
Long-Term Debt In July 2022, we entered into a credit agreement with CIBC as amended by the First Amendment to Credit Agreement, dated as of May 8, 2023, by and among the Company and CIBC, or the First Amendment, the Second Amendment to Credit Agreement, dated as of June 23, 2023, by and among the Company and CIBC, or the Second Amendment, and the Third Amendment to Credit Agreement, dated as of November 9, 2023, by and among the Company and CIBC, or the Third Amendment, pursuant to which we borrowed $60.0 million, referred to herein as the CIBC Credit Agreement.
If this condition or another conversion condition is met in the future, the Notes may again become convertible, otherwise the Notes will be convertible at the noteholders’ election from March 1, 2028 through the close of business on the second scheduled trading day immediately before the maturity date. 73 Long-Term Debt In July 2022, we entered into a credit agreement with CIBC as amended by the First Amendment to Credit Agreement, dated as of May 8, 2023, by and among the Company and CIBC, or the First Amendment, the Second Amendment to Credit Agreement, dated as of June 23, 2023, by and among the Company and CIBC, or the Second Amendment, and the Third Amendment to Credit Agreement, dated as of November 9, 2023, by and among the Company and CIBC, or the Third Amendment, pursuant to which we borrowed $60.0 million, referred to herein as the CIBC Credit Agreement.
During the year ended December 31, 2023, operating activities used $13.0 million of cash, primarily resulting from our net loss of $25.0 million and net cash used by changes in our operating assets and liabilities of $44.3 million, partially offset by net non-cash charges of $56.3 million, which included an IPR&D charge of $27.2 million.
During the year ended December 31, 2024, operating activities provided $48.8 million of cash, primarily resulting from our net income of $35.5 million and net non-cash charges of $58.3 million, partially offset by net cash used by changes in our operating assets and liabilities of $45.0 million.
Interest Income and Other Income (Expense), Net Interest income and other income (expense), net includes interest income, realized and unrealized foreign currency transaction gains and losses and other non-operating income and expense items unrelated to our core operations. Interest income consists of interest earned on our invested cash balances.
In May 2023, we issued and sold $460.0 million in aggregate principal amount of our Notes. Interest Income and Other Income (Expense), Net Interest income and other income (expense), net includes interest income, realized and unrealized foreign currency transaction gains and losses and other non-operating income and expense items unrelated to our core operations.
Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in our commercial team and personnel in executive, marketing, finance and administrative functions, and recruiting and temporary service fees for such personnel.
Acquired In-Process Research and Development Expenses Acquired in-process research and development expenses, or IPR&D, consist of the acquisition value of transactions that do not qualify as a business combination and that do not have an alternative future use. 67 Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in our commercial team and personnel in executive, marketing, finance and administrative functions, and recruiting and temporary service fees for such personnel.
Revenue is recognized when control is transferred to the customer in an amount that reflects the consideration we expect to be entitled to in exchange for the product or services.
Revenue from sales to customers of organ procurement, OCS perfusion management and transplant logistics services is classified as service revenue in our consolidated statements of operations. 76 Revenue is recognized when control is transferred to the customer in an amount that reflects the consideration we expect to be entitled to in exchange for the product or services.
Net cash used by changes in our operating assets and liabilities for the year ended December 31, 2023 consisted primarily of an increase in accounts receivable of $33.8 million, an increase in inventory of $28.1 million and an increase in prepaid expenses and other current assets of $2.1 million, partially offset by an increase in accounts payable and accrued expenses and other current liabilities of $21.2 million. 73 Changes in accounts receivable, inventory, prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities in each reporting period are generally due to growth in our business and timing of invoices and payments.
Net cash provided by changes in our operating assets and liabilities for the year ended December 31, 2025 consisted primarily of a decrease in accounts receivable of $14.0 million and a net increase in accounts payable and accrued expenses and other current liabilities of $17.7 million, partially offset by an increase in inventory of $7.7 million and an increase in prepaid expenses and other current assets of $3.8 million.
Consulting and third-party services costs increased by $7.1 million due to development efforts by our external development consultants for our next generation OCS, other product development and digital tools.
Consulting and third-party services costs increased by $2.6 million due to development efforts by our external development consultants for our next generation OCS program and other product development, including our kidney transport system. Clinical trial costs increased by $1.0 million due primarily to the initiation of clinical trial-related activities for our ENHANCE and DENOVO clinical trials.
During the year ended December 31, 2024, we acquired eight transplant-related fixed-wing aircraft with an aggregate purchase price of $109.6 million and we plan to acquire additional aircraft in 2025, including two aircraft purchased in January 2025 and February 2025 with an aggregate purchase price of $28.4 million.
We may acquire additional fixed-wing aircraft to enhance our logistics capabilities and support international expansion. During the year ended December 31, 2025, we acquired 3 transplant-related fixed-wing aircraft with an aggregate purchase price of $42.9 million.
Selling, General and Administrative Expenses Year Ended December 31, 2024 2023 Change (in thousands) Personnel related (including stock-based compensation expense) $ 109,475 $ 72,717 $ 36,758 Professional and consultant fees 18,313 17,401 912 NOP support 12,289 11,985 304 Tradeshows and conferences 4,328 4,575 (247 ) Facility related and other 24,212 12,875 11,337 Total selling, general and administrative expenses $ 168,617 $ 119,553 $ 49,064 Total selling, general and administrative expenses increased by $49.1 million from $119.6 million in the year ended December 31, 2023 to $168.6 million in the year ended December 31, 2024 due primarily to increases in personnel related costs, and facility related and other costs.
Facility related and other costs increased by $2.2 million from the year ended December 31, 2024 to the year ended December 31, 2025 due primarily to increased cost of supporting a larger group of research and development personnel. 70 Selling, General and Administrative Expenses Year Ended December 31, 2025 2024 Change (in thousands) Personnel related (including stock-based compensation expense) $ 114,506 $ 109,475 $ 5,031 Professional and consultant fees 25,936 18,313 7,623 NOP support 6,826 12,289 (5,463 ) Tradeshows and conferences 4,316 4,328 (12 ) Facility related and other 33,584 24,212 9,372 Total selling, general and administrative expenses $ 185,168 $ 168,617 $ 16,551 Total selling, general and administrative expenses increased by $16.6 million from $168.6 million in the year ended December 31, 2024 to $185.2 million in the year ended December 31, 2025.
Other Income (Expense) Interest Expense Interest expense was $14.4 million and $10.8 million for the years ending December 31, 2024 and 2023, respectively. The increase was due primarily to interest expense on the $460.0 million principal amount of the Notes, which were issued in May 2023.
Other Income (Expense) Interest Expense Interest expense was $13.8 million and $14.4 million for the years ending December 31, 2025 and 2024, respectively, and consisted of interest expense on the $460.0 million principal amount of the Notes that carry a 1.5% interest rate and interest expense on the $60.0 million principal amount of the CIBC loan that carries a variable interest rate, which was 5.7% as of December 31, 2025.
During the year ended December 31, 2023, net cash provided by financing activities of $400.4 million consisted of net proceeds from the issuance of our Notes of $445.4 million, partially offset by payments of $52.1 million for associated capped calls, proceeds from the issuance of common stock upon exercise of stock options of $6.2 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $1.0 million.
During the year ended December 31, 2024, net cash used in investing activities of $129.3 million consisted of purchases of property, plant and equipment of $129.7 million, primarily related to the purchase of transplant aircraft. 72 Financing Activities During the year ended December 31, 2025, net cash provided by financing activities of $16.9 million consisted of proceeds from the issuance of common stock upon exercise of stock options of $13.7 million and proceeds from the issuance of common stock in connection with the 2019 Employee Stock Purchase Plan of $3.2 million.
Facility related and other costs increased by $11.3 million due primarily to increased costs associated with post-approval studies and information technology infrastructure costs, and depreciation and amortization expense due to the growth in our business.
We also incurred higher consulting services related to general business initiatives to support our growth. Facility related and other costs increased by $9.4 million due primarily to increased depreciation and amortization and information technology infrastructure costs as well as increases in non-income based state taxes.
We have the right to elect to settle conversions either in cash, shares or in a combination of cash and shares of our common stock. 74 Prior to June 8, 2026, the Notes will not be redeemable.
Prior to June 8, 2026, the Notes will not be redeemable.
Comparison of the Years Ended December 31, 2023 and 2022 For a discussion of our results of operations for the year ended December 31, 2023 as compared to the year ended December 31, 2022, see Item 7.
Our effective tax rate for 2024 differs from the U.S. federal statutory income tax rate of 21.0% primarily due to excess stock compensation deductions, partially offset by state and federal income taxes for the portion of our taxable income that was not offset by operating loss and tax credit carryforwards, and the impact from the change in valuation allowance. 71 Comparison of the Years Ended December 31, 2024 and 2023 For a discussion of our results of operations for the year ended December 31, 2024 as compared to the year ended December 31, 2023, see Item 7.
Removed
Since 2023, we have offered logistics services through our NOP, including aviation transportation, ground transportation, and other coordination activity.
Added
We expect our operating and capital expenditures will continue to increase as we focus on growing commercial sales of our products in both the United States and select non-U.S. markets.
Removed
We expect our operating and capital expenditures will continue to increase as we focus on growing commercial sales of our products in both the United States and select non-U.S. markets, including growing our commercial team, which will pursue increasing commercial sales of our OCS products; growing our NOP, including by maintaining and growing our logistics capabilities, including hiring, training and retaining pilots to scale our aviation transportation operations, to support our NOP and reduce dependence on third party transportation, including by means of the acquisition, maintenance or replacement of fixed-wing aircraft or other acquisitions, joint ventures or strategic investments; scaling our manufacturing and sterilization operations; developing the next generation OCS; continuing research, development and clinical trial efforts; seeking regulatory clearance for new products and product enhancements, including additional indications or other organs, in both the United States and select non-U.S. markets; and operating as a public company.
Added
The United Network for Organ Sharing, or UNOS, operated the OPTN under a sole-vendor federal contract from 1986 until 2024. In March 2023, the U.S.
Removed
To a lesser extent, Summit also derived revenue from providing flight school training, managing aircraft and other related services. As part of the Summit integration, we transitioned Summit's charter flight and aircraft management customers to third parties. We do not anticipate generating revenue from charter flights or aircraft management and related services.
Added
In September 2024, HRSA began awarding contracts aimed at supporting the multi-vendor model. 65 HRSA has consistently exercised options to extend the contract for UNOS to operate OPTN, albeit in a more limited capacity, since March 2024. Most recently, in December 2025, HRSA and UNOS reached a new agreement that took effect on December 30, 2025.
Removed
We are continuing to offer flight school training services. During the years ended December 31, 2024 and 2023 service revenue of $4.4 million and $4.9 million, respectively, was from Summit's legacy operations, unrelated to the NOP and organ transplant.
Added
This contract allows HRSA to extend UNOS’ work for up to 12 months, until December 29, 2026, structured as four optional three-month periods. The new agreement reflects a shift of several former UNOS functions, including patient safety, reporting and tracking of donor-derived transmission events, and committee support, to HRSA or other contractors.
Removed
For the years ended December 31, 2024 and 2023, cost of service revenue also included approximately $3.1 million and $4.4 million, respectively, of costs related to Summit's legacy operations, unrelated to the NOP and organ transplant.
Added
HRSA continues to implement efforts to improve and modernize the OPTN, including enhancements to patient data on organ procurement, expanded transparency through a publicly accessible data dashboard for allocation out of sequence (AOOS) events, expanded outreach and financial support for living organ donors, and a new OPTN fee collection process whereby HRSA directly collects and distributes patient registration fees under authorities originally granted by the 2025 Full-Year Continuing Appropriations and Extensions Act and extended by the 2026 Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act.
Removed
Acquired In-Process Research and Development Expenses Acquired in-process research and development expenses, or IPR&D, consist of the acquisition value of transactions that do not qualify as a business combination and that do not have an alternative future use.
Added
Interest income consists of interest earned on our cash balances. Foreign currency transaction gains and losses result from intercompany transactions as well as transactions with customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded.
Removed
At that time, we repaid the remaining $35.0 million of principal that had been outstanding under our prior credit agreement with OrbiMed Royalty Opportunities II, LP, or OrbiMed. In May 2023, we issued and sold $460.0 million in aggregate principal amount of our 1.50% convertible senior notes, due 2028.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeAs of December 31, 2024 borrowings outstanding under the CIBC Credit Agreement totaled $60.0 million and the interest rate applicable to such borrowings was 6.4%. An immediate 10% change in the Federal Funds Effective Rate would not have a material impact on our debt-related obligations, financial position or results of operations.
Biggest changeAs of December 31, 2025 the outstanding principal under the CIBC Credit Agreement totaled $60.0 million and the interest rate applicable to such borrowings was 5.7%. An immediate 10% change in the Federal Funds Effective Rate would not have a material impact on our debt-related obligations, financial position or results of operations.
Item 7A. Quantitative and Qualitati ve Disclosures About Market Risk. We are exposed to changes in interest rates and foreign currency exchange rates because we finance certain operations through variable rate debt instruments and denominate our transactions in a variety of foreign currencies. Changes in these rates may have an impact on future cash flow and earnings.
Item 7A. Quantitative and Qualitati ve Disclosures About Market Risk. We are exposed to changes in interest rates and foreign currency exchange rates because we finance certain operations through variable rate debt instruments and denominate transactions in a variety of foreign currencies. Changes in these rates may have an impact on future cash flow and earnings.
Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of our savings accounts, an immediate 10% change in interest rates would not have a material effect on the fair market value of our cash balance. 79 In July 2022, we entered into our CIBC Credit Agreement with CIBC.
Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of our savings accounts, an immediate 10% change in interest rates would not have a material effect on the fair market value of our cash balance. In July 2022, we entered into our CIBC Credit Agreement with CIBC.
For the year ended December 31, 2024, 3% of our revenue and 2% of our operating costs and expenses were generated by subsidiaries whose functional currency is not the U.S. dollar and therefore are subject to foreign currency exposure. Currently, our largest foreign currency exposure is that with respect to the Euro.
For the year ended December 31, 2025, 2% of our revenue and 3% of our operating costs and expenses were generated by subsidiaries whose functional currency is not the U.S. dollar and therefore are subject to foreign currency exposure. Currently, our largest foreign currency exposure is that with respect to the Euro.
Assets and liabilities arising from such transactions are translated into the legal entity’s functional currency using the period-end exchange rates. Foreign currency transaction gains (losses) are included in the consolidated statements of operations as a component of other income (expense). We recognized foreign currency transaction losses of $0.7 million during the year ended December 31, 2024.
Assets and liabilities arising from such transactions are translated into the legal entity’s functional currency using the period-end exchange rates. Foreign currency transaction gains (losses) are included in the consolidated statements of operations as a component of other income (expense). We recognized foreign currency transaction gains of $1.0 million during the year ended December 31, 2025.
The Notes have a fixed annual interest rate of 1.50%. Accordingly, we do not have interest rate exposure on the Notes. 80
The Notes have a fixed annual interest rate of 1.50%. Accordingly, we do not have interest rate exposure on the Notes. 78
The effects of these foreign currency translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’ equity on our consolidated balance sheets. We recorded a foreign currency translation loss of $0.2 million during the year ended December 31, 2024.
The effects of these foreign currency translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’ equity on our consolidated balance sheets. We recorded a foreign currency translation gain of $0.5 million during the year ended December 31, 2025.
Interest Rate Sensitivity As of December 31, 2024, we had cash of $336.7 million, including cash held in savings accounts.
Interest Rate Sensitivity As of December 31, 2025, we had cash of $488.4 million, including cash held in savings accounts.

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